| ID | Title | Description | Link | Resource Tags | Regions / Countries | Costs |
|---|---|---|---|---|---|---|
| 3532 | Principles of Clinical Pharmacology | This course is a free, online, asynchronous lecture series available to participants around the world. The course covers the fundamentals... | [Link] | Certification Available Registration Required | Free | |
| 3234 | USP-NF/PF Overview (Tutorial) | Learn how to navigate the USP–NF and PF information online. An overview of the system and answers to common questions,... | [Link] | On-Demand Registration Required | Global | Varies |
| 3233 | Introduction to USP's Pending Monograph Process (PMP) (Webinar & Q&A) | The Pending Monograph Process (PMP) is a successful collaboration developed between the USP and FDA to allow monograph revisions to... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3232 | USP SEPC: Changes to USP-NF Publication Model | In July of 2025, USP will be implementing changes to the USP publication schedule. This course details the Changes to... | [Link] | On-Demand Registration Required | Global | Varies |
| 3231 | Setting the Standard: USP’s Journey in Global Health | This course offers a comprehensive overview of the U.S. Pharmacopeia (USP), exploring its mission, organizational structure, and global influence in... | [Link] | eLearning Registration Required | Global | Varies |
| 3229 | The Medicines Risk-based Surveillance (MedRS) tool for post-marketing surveillance: Introductory overview of key features and use | The Medicines Risk-based Surveillance (MedRS) tool is a free web-based platform that automates the development of sampling protocols for post-marketing... | [Link] | On-Demand Registration Required | Global | Varies |
| 3228 | Medical Devices Standards and Classifications: Focus on Maternal Neonatal and Child Health (MNCH) | This course focuses on the regulation of medical devices and is self-paced. It is made up of three lessons: Lesson... | [Link] | eLearning Registration Required | Global | Varies |
| 3221 | Proposed Revision to USP Nuclear Magnetic Resonance Spectroscopy-Theory and Practice | The US Pharmacopeial Convention (USP) solicited public comments on the draft revision of USP General Chapter Nuclear Magnetic Resonance Spectroscopy-Theory... | [Link] | On-Demand Registration Required | Global | Varies |
| 3220 | Proposed Revision to USP Nuclear Magnetic Resonance Spectroscopy | The US Pharmacopeial Convention (USP) solicited public comments on the draft revision of USP General Chapter Nuclear Magnetic Resonance Spectroscopy... | [Link] | On-Demand Registration Required | Global | Varies |
| 3219 | Quantitative NMR Good Weighing Practices and Measurement Uncertainty | A key step in quantitative NMR (qNMR) testing is the weighing of standards and samples, as the accuracy of qNMR... | [Link] | On-Demand Registration Required | Global | Varies |
| 3218 | qNMR in Complex Drug Product Quality: From Benchtop to High-Resolution | qNMR is a versatile tool that can quickly and accurately identify and quantify chemical components of both complex and biological... | [Link] | On-Demand Registration Required | Global | Varies |
| 3217 | Pharmacopeial Applications of qNMR: A Selection of Vignettes | This presentation highlights four projects where NMR spectroscopy has been applied to solve analytical challenges over the years, each with... | [Link] | On-Demand Registration Required | Global | Varies |
| 3216 | Drug Quality Control Applications for qNMR | Quantitative nuclear magnetic resonance (qNMR) is a powerful tool for measuring drug content due to its high speed, sensitivity, and... | [Link] | On-Demand Registration Required | Global | Varies |
| 3215 | Development of a Reference-Free Quantification Method Using qNMR and Chromatography | Many reference materials for target analytes are not commercially available. This causes a problem in the regulatory or health authority... | [Link] | On-Demand Registration Required | Global | Varies |
| 3214 | qNMR under GxP—Automated End-to-End Solution | It is critical to comply with 21 CFR p11 and the principles of data integrity when working under GxP during... | [Link] | On-Demand Registration Required | Global | Varies |
| 3213 | Interlaboratory Comparison of Benchtop NMR Spectrometers | Due to its advantages of being a direct comparison method, quantitative NMR spectroscopy (qNMR) becomes increasingly popular in industry. While... | [Link] | On-Demand Registration Required | Global | Varies |
| 3212 | Proposed Revisions to USP General Chapters & | USP General Chapters and are currently being revised by an Expert Panel. Since the last revision in 2013, there has... | [Link] | On-Demand Registration Required | Global | Varies |
| 3211 | Compact NMR Spectroscopy for Automated Continuous-Flow Production of Chemicals and Pharmaceuticals | Chemical companies are under constant pressure to improve productivity while cutting costs. Flexible and modular chemical plants can produce high-quality... | [Link] | On-Demand Registration Required | Global | Varies |
| 3210 | Determining Purity with Benchtop 1H NMR | High-field NMR instruments are excellent at chemical structure elucidation and quantitation, but their size and complexity mean that these instruments... | [Link] | On-Demand Registration Required | Global | Varies |
| 3209 | Improving Accuracy of Benchtop qNMR for Samples with Protonated Solvents | Strong spectral signatures from typical protonated solvents in liquid formulations present challenges for the quantification of analytes by NMR. In... | [Link] | On-Demand Registration Required | Global | Varies |
| 3207 | USP Standards: Roles and Responsibilities for Pharmacy Leaders | This course of the education offering is meant for Pharmacy Leaders responsible for the understanding, support and implementation of USP... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3206 | USP Standards: Roles & Responsibilities for Institution Leaders | The USP Institution Solution is an eLearning, practice-centric, comprehensive training program that helps hospital staff meet quality and compliance expectations... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3205 | Interpreting USP Compounded Preparation Monographs in Compounding Practice | USP Compounded Preparation Monographs (CPMs) are published after extensive review and testing by the USP Compounding Expert Committee. While most... | [Link] | On-Demand Registration Required | Global | Varies |
| 3204 | eLearning: USP Hazardous Drugs—Handling in Healthcare Settings for Compounding Professionals | This 6.5-hour eLearning course, delivered through an innovative, interactive, online format, aims to improve your knowledge in the implementation of... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3203 | USP-NF General Chapter Hazardous Drugs - Handling in Healthcare Setting | This course discusses key requirements in USP General Chapter Hazardous Drugs—Handling in Healthcare Settings. The course will describe the standards... | [Link] | Classroom On-Demand Registration Required | Global | Varies |
| 3201 | eLearning: USP Pharmaceutical Compounding—Sterile Preparations for Compounding Professionals | This eLearning course, delivered through an innovative, interactive, online format, aims to improve your knowledge in the implementation of USP... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3200 | USP General Chapter Pharmaceutical Compounding - Sterile Preparations | This course aims to improve your knowledge in the implementation of USP General Chapter Pharmaceutical Compounding—Sterile Preparations. The course describes... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3199 | eLearning: USP Pharmaceutical Compounding—Nonsterile Preparations for Compounding Professionals | This eLearning course, delivered through an innovative, interactive, online format, aims to improve your knowledge in the implementation of USP... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3198 | USP General Chapter Pharmaceutical Compounding - Nonsterile Preparations | The course describes the scope of USP , outlines the responsibilities of compounders, defines the criteria for component selection and... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3197 | Labeling Requirements for Prescription Drugs, Updates, and Future Direction for Chapter | Medication misuse has resulted in more than 1 million adverse drug events per year in the United States. Patients’ best... | [Link] | On-Demand Registration Required | Global | Varies |
| 3196 | USP Pharmaceutical Calculations | This course will provide general information to assist pharmacists, pharmacy technicians, and pharmacy students in performing calculations for compounding and... | [Link] | eLearning Registration Required | Global | Varies |
| 3195 | Physical Environments that Promote Safe Medication Use | Work environment has been identified as one of the most common factors contributing to medication errors reported to USP. The... | [Link] | On-Demand Registration Required | Global | Varies |
| 3193 | Pharmaceutical Quality Practices: Change Control Management | This course introduces change control management . It will cover regulatory guidelines for change reporting. Subject area: cGMP Objectives (If... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3192 | Audit Fundamentals Theory | This course introduces the audit process, planning, data review, reporting and CAPA. Participants will experience applicable template based discussions on... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3191 | Deviation Investigations Including RCA | This course provides an overview of deviations, regulatory guidelines, investigation roles and responsibilities as well as stages of investigation. Investigation... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3190 | Corrective and Preventive Action (CAPA) | This course provides a brief overview of the CAPA life cycle, roles and responsibilities, implementation, verification, effectiveness check. Regulatory consequences... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3187 | From Experimental to Accepted: How In-Silico Modeling is Redefining CMC with Regulatory Confidence | This webinar explores the transformation of in-silico modeling from an experimental tool into a regulatory-accepted element of pharmaceutical Chemistry, Manufacturing,... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3186 | Cell & Gene Therapy, Manufacturing & Quality | The success of autologous CAR-T therapies such as Kymriah® and YESCARTA® marked a turning point in cell and gene therapy... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3185 | PCM-Continuous Manufacturing: Presenting Your Business Case | For drug innovators, CDMOs, Over the Counter (OTC), or generics manufacturers, knowing how and when to adopt pharmaceutical continuous manufacturing... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3184 | The Basic of a PCM Control Strategy: Material Characterization | Measurement tools and models give a deeper understanding of process behaviors, like viewing your process in a higher resolution. During... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3183 | EU Annex 1 in Full Effect: Are Manufacturers with EU Drug Product Prepared? | Annex 1 is an opportunity for industry to emphasize advanced technologies and for Pharma companies to speed up their processes... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3182 | PCM for Drug Substance (API) | Continuous processing is a viable alternative manufacturing method to batch production for small-molecule API. This webinar provides exploration of Pharmaceutical... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3181 | Entering the U.S. Markets: What Does it Take? | This webinar will address the most important steps in a roadmap to bring biosimilar, generic, and complex generic drugs through... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3180 | PCM and Regulatory: It's All About the Data | This webinar will guide you through the expctations of regulators when filling a Pharmaceurtical Continuous Manufacturing (PCM) process for an... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3179 | PCM and Quality: Upgrade Your Resolution | In process development of a Pharmaceutical Continuous Manufacturing (PCM) oral solid dose (OSD) drug product, the goal is to identify... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3178 | Modern Quality Techniques: Patient-centric Processes, Integrated QMS, Regulatory Intelligence | For an organization to move to and thrive in a culture of quality involves having consistent, reliable, robust business processes... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3177 | PCM Equipment Design: Bringing the Pieces Together | This webinar brings an overview of what the design elements of a PCM line look like, and how they work... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3176 | PCM: What is the Best Business Strategy for You? | As a company producing Oral Solid Dose drug product, how can Pharmaceutical Continuous Manufacturing (PCM) solve specific problems and help... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3175 | What You Need to Know About the EU GMP Annex 1 Revision | The final version of EU GMP Annex 1 is an opportunity for industry to apply solutions that emphasize advanced technologies... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3174 | Quality Considerations for a Robust Data Integrity Program | Quality, with its checks and balances, is the foundation and a key to success for your pharma startup. A proactive,... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3173 | Applying Process Analytical Technology (PAT) to Support Real Time Release (RTR) | PAT is an enabler for designing quality into a product when quality by design (QbD) principles are applied, with opportunities... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3172 | Quality Considerations for Aseptic Processing | Requirements for aseptic manufacturing were raised at a time when there was no suitable sterilization method for heat-sensitive pharmaceutical products... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3171 | Cell and Gene Therapy Innovations to Drive Down Costs, Increase Efficiency | Cell and gene therapy is lifesaving for specific and formerly untreatable medical conditions. Very high costs are associated with manufacturing... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3170 | The Difference Between Compliance and Quality | Our journey from compliance to quality is rooted in deep traditions, but are those traditions helping us or hurting us?... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3169 | Continuous Manufacturing for Pharmaceutical Solid Dosage Forms | This course is a blended learning opportunity during which participants will engage in self-paced modules and live virtual education to... | [Link] | Blended eLearning Registration Required | Global | Varies |
| 3168 | Good Manufacturing Practices in the Quality Control Laboratory | This introduction course provides a groundwork for further exploration and application of GMP principles in the quality control laboratory setting.... | [Link] | eLearning Registration Required | Global | Varies |
| 3167 | Pharmaceutical Quality Management Systems: Elements and Quality Review Practice | This course provides an introduction to a Quality Management Systems (QMS) and Pharmaceutical Quality Systems (PQS) in the pharmaceutical industry,... | [Link] | eLearning Registration Required | Global | Varies |
| 3166 | Foundations of GMP | Pharmaceutical manufacturers must comply with the regulatory requirements of the countries where they produce and sell medical products. This free,... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3165 | Foundations of GMP: Water Systems | This eLearning course aims to improve your knowledge and understanding of Good Manufacturing Practice (GMP) requirements of water for usage... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3164 | Foundations of GMP: Heating, Ventilation, and Air Conditioning (HVAC) Systems | This eLearning course aims to improve your knowledge and understanding of Good Manufacturing Practice (GMP) requirements of heating, ventilation, and... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3163 | Foundations of GMP: Auditing | This eLearning course aims to improve your knowledge and understanding of performing Good Manufacturing Practice (GMP) compliance audit. Subject area:... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3162 | Foundations of GMP: Data Integrity and Computer System Validation | This eLearning course aims to improve your knowledge and understanding of Good Manufacturing Practice (GMP) requirements of computer system validation... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3161 | Foundations of GMP: Qualification | This eLearning course aims to improve your knowledge and understanding of Good Manufacturing Practice (GMP) requirements for facility, equipment and... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3160 | Foundations of GMP: Validation | This eLearning course aims to improve your knowledge and understanding of Good Manufacturing Practice (GMP) requirements for validation life cycle,... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3159 | Foundations of GMP: Deviations, Root Cause Analysis (RCA) Tools and Corrective and Preventive Action (CAPA) - Sequence flow for handling of any non-conformance in the GMP environment | This eLearning course aims to improve your knowledge and understanding of Good Manufacturing Practice (GMP) requirements for handling deviations, using... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3158 | Foundations of GMP: Quality Risk Management | This eLearning course aims to improve your knowledge and understanding of Good Manufacturing Practice (GMP) requirements for Quality Risk Management... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3157 | Foundations of GMP: Active Pharmaceutical Ingredient (API) | This eLearning course aims to improve your knowledge and understanding of Good Manufacturing Practice (GMP) requirements for Active Pharmaceutical Ingredient... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3156 | Foundations of GMP: Final Dosage Form | This eLearning course aims to improve your knowledge and understanding of Good Manufacturing Practice (GMP) requirements for Pharmaceutical manufacturers. Subject... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3155 | Data Assurance Throughout Product Lifecycle (CXO) | This course provides an overview of regulatory expectations for data integrity including USFDA, WHO and PIC/s as well as relevant... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3154 | The Challenge of Ensuring Food Quality in a Growing Complex Food Supply Chain | This video discusses the growing complexity of the food ingredient supply chain and introduces USP and its role in food... | [Link] | On-Demand Registration Required | Global | Varies |
| 3153 | Impact of Lipids on the Design and Quality of Liposomal Drug Products | The liposomal “commercial” lipid pool has little variation, and “fancy” lipids (e.g., potentially useful for gene and DNA/RNA delivery, immunological... | [Link] | On-Demand Registration Required | Global | Varies |
| 3152 | The Role and Influence of Excipients in Orally Inhaled Drug Products | Orally inhaled products contain formulation excipients, the effects of which on quality, performance, safety and efficacy must be considered. Only... | [Link] | On-Demand Registration Required | Global | Varies |
| 3151 | Impact of Excipients on Inhalation Drug Products | Differing levels of excipients within inhalation products may have a significant impact on product performance and, from a scientific and... | [Link] | On-Demand Registration Required | Global | Varies |
| 3150 | Why Do We Call Excipients in Topical Products “Inactive Ingredients”? | This presentation discussed the complex functionality of “inactive” ingredients in topical semisolid drug products, and elucidated how topical excipients exert... | [Link] | On-Demand Registration Required | Global | Varies |
| 3149 | Safety Assessments for Excipients in Generic Drugs: A Regulatory Perspective | Excipients in generic drug products are evaluated from clinical and nonclinical perspectives to ensure that they do not alter the... | [Link] | On-Demand Registration Required | Global | Varies |
| 3148 | Improved Excipient Characterization Beyond USP Monographs | This presentation focused on understanding USP–NF excipient monographs and the structural/functional properties of excipients, including the role of each in... | [Link] | On-Demand Registration Required | Global | Varies |
| 3147 | Understanding the Impact of Material Attributes on Product Quality for Continuous Manufacturing | For continuous manufacturing processes, the impact of variation in material attributes on material feeding and process dynamics should be characterized... | [Link] | On-Demand Registration Required | Global | Varies |
| 3146 | Introduction to Pharmaceutical Excipients | Excipients are a very diverse group of materials. They are not active pharmaceutical ingredients (APIs), pharmaceutical finished products or simply... | [Link] | On-Demand Registration Required | Global | Varies |
| 3145 | Opening Remarks, Goals and Anticipated Outcomes | The goals of the workshop included the following: Advance the science of excipient selection and regulatory evaluation. Emphasize that regulatory... | [Link] | On-Demand Registration Required | Global | Varies |
| 3144 | USP SEPC: Evolving Iterative Approaches for Excipients GCs (312 to 316) and LG Polymers | This session will examine the development of General Chapters to as modern analytical tools for use with individual monographs. The... | [Link] | On-Demand Registration Required | Global | Varies |
| 3143 | Atypical Actives – Industry Perspective | Priscilla Zawislak, Chair, IPEC-Americas This presentation from the USP Excipient Stakeholder Forum covers the industry’s perspective on atypical actives, including... | [Link] | On-Demand Registration Required | Global | Varies |
| 3142 | An FDA Perspective on FDA Atypical Active Ingredients | Steven Wolfgang, Ph.D. Center for Drug Evaluation and Research Office of Compliance Office of Drug Security, Integrity and Response This... | [Link] | On-Demand Registration Required | Global | Varies |
| 3141 | USP Perspective on Atypical Actives | Catherine Sheehan, Sr. Director, Science – Excipients, USP This presentation from the USP Excipient Stakeholder Forum covers USP quality standards... | [Link] | On-Demand Registration Required | Global | Varies |
| 3140 | Overview of USP-NF GMP General Chapters Relevant to Excipients | This course will explore the nature of excipients and how they differ from active pharmaceutical ingredients and pharmaceutical finished products.... | [Link] | Blended On-Demand Registration Required | Global | Varies |
| 3139 | Overview of the USP-NF (Complimentary) | This webinar provides an overview of the USP–NF online resource and compendial standards. Attendees will learn about USP Reference Standards... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3138 | What You Always Wanted to Know About USP Reference Standards | This course will provide basic information on USP Reference Standards as highly characterized chemical specimens required for use in USP–NF... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3137 | Introduction to USP Reference Standards | This course will provide information on USP Reference Standards as highly characterized chemical specimens required for use in USP–NF compendial... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3136 | Dietary Supplement-Verification Program Overview | This 60-minute live webinar will inform existing participants, as well as potential customers, about USP and the Dietary Supplement Verification... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3135 | 2024 USP/US FDA Dietary Supplements Workshop | This recorded video brings together experts from US FDA and USP on dietary supplement regulations (DSHEA and 21CFR111), US cGMP... | [Link] | On-Demand Registration Required | Global | Varies |
| 3134 | Overview of Dietary Supplements Regulations in the United States | This one-hour webinar provides an overview of dietary supplements regulations past, present and future. It will cover the evolution of... | [Link] | eLearning Live Webcast On-Demand Registration Required | Global | Varies |
| 3133 | Complimentary Webinar on Nomenclature Guidelines for Dietary Supplements | This webinar explains in detail, with examples, how monograph titles for botanical and non-botanical dietary supplements will be formulated in... | [Link] | On-Demand Registration Required | Global | Varies |
| 3132 | Product Quality Verification of Dietary Supplements | Patients have thousands of dietary supplement options available to them in today's market. Many of these patients will ask you,... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3131 | Current Good Manufacturing Practices (cGMPs) for Dietary Supplements, 21 CFR Part 111 | Expand your knowledge of key elements of cGMPs per 21 CFR Part 111: personnel, physical plants, equipment, production/process control system,... | [Link] | On-Demand Registration Required | Global | Varies |
| 3130 | Botanical ID Methodology Tests | This course offers an overview of the botanical identification methodologies codified in the USP General Chapters Identification of Articles of... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3129 | USP General Chapter 2251 Adulteration of Dietary Supplements with Drugs and Drug Analog | This webinar will expand the audience’s understanding of the scope and magnitude of adulteration of dietary supplements, provide methodological insight,... | [Link] | On-Demand Registration Required | Global | Varies |
| 3128 | Cannabis Quality for Clinical Investigations – Proposed General Chapter | This webinar will describe the validated analytical methods for testing cannabinoid and terpene content, and the relevant USP General Chapters... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3127 | The Either-Or Trap: Consequences of Enhanced Mechanical Calibration vs. Fully Qualifying Dissolution Equipment | This webinar will review how dissolution and drug release testing are used to demonstrate the consistency of pharmaceutical product performance... | [Link] | On-Demand Registration Required | Global | Varies |
| 3123 | USP Medicine Supply Map Workflow Animation Video | The USP Medicine Supply Map (MSM) Animation Video provides users with an overview of the supply chain intelligence tool and... | [Link] | On-Demand Registration Required | Global | Varies |
| 3120 | Introduction to the USP Remdesivir Toolkit | As part of USP’s response to the COVID-19 crisis, a Remdesivir Toolkit containing analytical procedures (e.g., IR, UPLC, NMR, LC-MS)... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3119 | Quality Attributes of Drug Products Applied to the Skin | This webinar will discuss the main critical quality attributes that should be monitored and controlled during product development and/or for... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3118 | Dissolution Apparatus Qualification: USP Guideline on Procedures for Mechanical Qualification and Performance Verification Test: Apparatus 1 and Apparatus 2 | The purpose of these videos is to provide a detailed description of the best practices associated with the Mechanical Qualification... | [Link] | On-Demand Registration Required | Global | Varies |
| 3117 | Pharmaceutical Stability | Learn about essential components for designing global stability programs for pharmaceutical products: regulations, operations, testing, and investigations. Topics include cGMP,... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3116 | USP Bridging Study on DPVS-Prednisone Reference Standard | This webinar will cover specifications for Dissolution Performance Verification Standard – Prednisone Reference Standards (DPVS-Prednisone RS) that were developed and... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3115 | USP Certificate of Lab Procedures | The USP Certificate of Lab Procedures gives prospects a comprehensive understanding of the USP Standards that are applicable and essential... | [Link] | On-demand Certificate Registration Required | Global | Varies |
| 3114 | USP Certificate on Impurities | The USP Certificate on Impurities provides prospects with a comprehensive understanding on USP’s risk-based approach to impurity standards and their... | [Link] | On-demand Certificate Registration Required | Global | Varies |
| 3113 | USP Certificate of Pharmacopeial Analysis | The USP Certificate of Pharmacopeial Analysis provides prospects with the knowledge necessary for analytical validation, verification and transfer and the... | [Link] | On-demand Certificate Registration Required | Global | Varies |
| 3112 | USP Certificate of Document and Reference Standards | The USP Certificate of Document and Reference Standards provides prospect with the knowledge of the effective use of USP standards... | [Link] | On-demand Certificate Registration Required | Global | Varies |
| 3110 | Uniformity of Dosage Units: USP–NF General Chapter | USP General Chapter Uniformity of Dosage Units is internationally harmonized and has been official since USP 34–NF 29 (2011). A... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3109 | Test for Asbestos in USP Talc Chapters and | This course will address the implementation of updated tests for asbestos in the USP Talc monograph and associated chapters and... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3108 | Spectroscopy: General Chapters and Technique-Specific Applications | This course will provide essential training and tools to assist the generation of spectroscopic measurement data that is ‘fit for... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3107 | Bacterial Endotoxin Testing (Lecture Only) | This course provides an understanding of the significance of endotoxin testing in ensuring product safety and compliance with regulatory standards.... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3106 | Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging | The Radiopharmaceuticals – Preparation, Compounding, Dispensing and Repackaging course will expand upon the uniform minimum standards for the preparation, compounding,... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3105 | All the Particulars on Particles: Silicone Oil Droplets | This webinar series will update you on the latest USP developments in Particulate Matter. Silicone oil is present as a... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3104 | All the Particulars on Particles: Gray Zone Particles | This webinar series will update you on the latest USP developments in Particulate Matter. This webinar will focus on gray... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3103 | All the Particulars on Particles: Visible Particles - USP General Chapters , , and | This webinar series will update you on the latest USP developments in Particulate Matters. This webinar will focus on USP... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3102 | All the Particulars on Particles Subvisible Particles—USP General Chapters 787, 788, 1787, and 1788 | This webinar series will update you on the latest USP developments in Particulate Matter. This webinar will focus on USP... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3101 | All the Particulars on Particles: Introduction to Compendial Particulate Standards | This webinar series will keep you informed of the latest USP developments on Particulate Matters. For this introductory session, we... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3100 | Determining Particulate Matter in Liquids: Parenteral & Ophthalmic Products | This course will focus on the current USP General Chapters Particulate Matter in Injections and Methods for the Determination of... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3099 | All the Particulars on Particulates - Ophthalmic Products | This webinar series will update you on the latest USP developments in Particulate Matter. This webinar will focus on USP... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3098 | NMR General Chapters and Best Practices for Compliance | This course covers General Chapters and , highlighting key advancements in Nuclear Magnetic Resonance Spectroscopy (NMR) and quantitative NMR (qNMR)... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3097 | Dissolution/Drug Release tests of Drug Products Applied to the Skin | This webinar will discuss USP General Chapters and and will present the equipment, most common conditions, and challenges for the... | [Link] | On-Demand Registration Required | Global | Varies |
| 3096 | Fundamentals of Dissolution: Guidance for the Verification and Qualification of a Dissolution Apparatus | This course will emphasize the fundamentals of dissolution testing of solid oral dosage forms and address specifics related to the... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3095 | Use of Enzymes in the Dissolution Testing of Gelatin Capsules | This webinar discusses the procedure to be used in the dissolution testing of gelatin capsules when they fail the two-tier... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3094 | Introduction to Rapid Microbiological Methods (RMMs) | This course provides an in-depth understanding of microbiological practices in the pharmaceutical industry, emphasizing the latest advancements in rapid microbiological... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3093 | Water Conductivity: USP General Chapter | USP General Chapter Water Conductivity is the primary method for determining inorganic/ionic impurities in Purified Water and Water for Injection... | [Link] | On-Demand Registration Required | Global | Varies |
| 3092 | Total Organic Carbon: USP General Chapter | USP General Chapter Total Organic Carbon (TOC) is official and it has been adopted by other pharmacopoeias as the primary... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3091 | Compendial HPLC Practices | This course covers USP General Chapter Chromatography, with focus on system suitability parameters and adjustments allowed to the chromatographic system.... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3089 | Inhalation and Nasal Products | This course focuses on the major aspects related to the quality and performance of aerosols and inhaled medications as described... | [Link] | Blended Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3088 | Microbiology and Sterility Assurance | This course offers participants a comprehensive insight into USP requirements for microbiology and sterility assurance. Additionally, it provides guidelines for... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3087 | User-Determined Reporting Thresholds | Measurement tools and models give a deeper understanding of process behaviors like viewing your process in a higher resolution. During... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3086 | Impurities in Drug Products and Drug Substances - A USP Approach | This course integrates ICH Guidance and FDA policy for impurities, relevant USP General Chapters about impurities, and USP’s approach to... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3085 | USP General Chapters Residual Solvents and Residual Solvents-Verification of Compendial Procedures | This course focuses on the control of residual solvents in pharmaceutical products to ensure patient safety. It is primarily based... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3084 | Understanding USP Requirements for Balances | This course discusses in detail, with examples, the USP requirements on balances and USP perspectives of Weighing on an Analytical... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3082 | Good Pharmaceutical Packaging: Extractables and Leachables (1-day) | The course will address the increased regulatory concerns regarding extractables and leachables related to the interaction of drug products with... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3081 | Good Pharmaceutical Packaging: Extractables and Leachables (1-1/2 day) | This course focuses on extractables and leachable(E&L) as it relates to the interaction between drug products and their various contact... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3080 | USP Nitrosamines Impurities On- Demand Video Tutorials | Nitrosamines are a critical topic for regulators and industry given the recent safety recalls of several products containing these impurities.... | [Link] | On-Demand Registration Required | Global | Varies |
| 3079 | USP Nitrosamines Impurities | Nitrosamines are a critical topic for regulators and industry given the recent safety recalls of several products containing this impurity.... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3078 | Pharmaceutical Waters | This two-day course explains compendial and regulatory requirements for source waters, purified water, water for injection(s), sterile water for injection... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3077 | USP–NF General Chapter – Microbial Control of Pharmaceutical Water Systems | Much of USP–NF General Chapter Water for Pharmaceutical Purposes is devoted to instructing the water system owner/user of the issues... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3076 | Validation of Pharmaceutical Water System: USP General Chapter | Pharmaceutical water systems must be appropriately designed, operated, and maintained in order to produce high quality water. USP General Chapter... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3075 | Microbiological Analysis of Pharmaceutical Water: USP General Chapter | Pharmaceutical Water Systems must be appropriately maintained in order to produce high quality water. USP General Chapter Water for Pharmaceutical... | [Link] | On-Demand Registration Required | Global | Varies |
| 3074 | Sterilization and Sterility Assurance | This course will offer participants a comprehensive insight into USP requirements for microbiology and sterility assurance in the context of... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3073 | Validation, Verification and Transfer of Analytical Procedures | Learn about parameters for validating analytical procedures for small molecules based on USP−NF General Chapters Validation of Compendial Procedures and... | [Link] | Classroom On-Demand Registration Required | Global | Varies |
| 3072 | Validation and Verification of USP Microbiological Methods | This course provides detailed parameters on validation and verification of microbiological tests, recovery from pharmacopeial articles, and validation criteria for... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3070 | Analytical Procedure Life Cycle and Application of the AQbD Approach | Based on USP General Chapter , this course provides an understanding of how to apply the Analytical Procedure Life Cycle... | [Link] | Blended Classroom eLearning Live Webcast Registration Required | Global | Varies |
| 3069 | USP General Chapter Statistical Tools for Procedure Validation | This course introduces key components of USP–NF General Chapter Statistical Tools for Procedure Validation. This chapter provides statistical concepts used... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3068 | Container Closure Integrity: Methods & Application | This course discusses the USP Package Integrity Evaluation series of general chapters. This course will focus on the practical aspects... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3067 | Overview of USP Microbiology Chapters | This course establishes an understanding of microbiological best practices, classical (culture-based) and alternative, their advantages and disadvantages and their validation... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3066 | Development and Validation of Dissolution Procedures | This course discusses the recommendations for dissolution method development and validation stated in the USP General Chapter . Building on... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3065 | Impurities and Forced Degradation Studies | This course will cover the main aspects related to the control of impurities in drugs and medicines and the application... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3064 | Risks and Mitigation Strategies on the Storage and Transport of Finished Drug Products | This course will cover the main aspects USP General Chapter Supply Chain Risks and Mitigation Strategies on the Storage and... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3063 | Enhancement of General Chapter Analytical Instruments and Systems Qualification; a full lifecycle approach | United States Pharmacopoeia (USP) has two General Chapters summarizing the lifecycle approaches and requirements to ensure data quality by demonstrating... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3062 | Process Analytical Technology Theory and Practice | USP General Chapter Process Analytical Technology – Theory and Practice has been published in USP’s Pharmacopeial Forum for public comments.... | [Link] | On-Demand Registration Required | Global | Varies |
| 3061 | Good Documentation Practices (GDP) and Record Keeping Best Practices | . Good Documentation Practices (GDP) is an essential element in regulated manufacturing and laboratory environments. Personnel working in these fields... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3060 | Good Documentation Practices (GDP) and USP–NF General Chapter | Good Documentation Practices (GDP) is essential in regulated manufacturing and laboratory environments. Personnel in these fields need to closely adhere... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3059 | USP Analytical Data – Interpretation and Treatment | This course expands on the key elements of USP–NF General Chapter concerning acceptable statistical concepts and practices for the analysis... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3057 | USP Standards to Support Quality of COVID-19 Vaccines for the Global Community | As researchers and manufacturers develop and produce vaccines to protect against COVID-19 and other infectious agents, it is critical to... | [Link] | On-Demand Registration Required | Global | Varies |
| 3056 | COVID 19 Vaccine Distribution and Storage: Increasing Access to Quality, Safe, and Effective Vaccine Products | In June 2021, the leaders from the Group of Seven industrialized nations committed to sharing at least 1 billion COVID-19... | [Link] | On-Demand Registration Required | Global | Varies |
| 3055 | Analysis of Charge Variants in Biologics | This course explains why measurement of charge variants is important. It will also describe multiple techniques (i.e., ion exchange chromatography,... | [Link] | On-Demand Registration Required | Global | Varies |
| 3054 | mRNA Open Forum: Collaborating to pave the way for mRNA-based vaccines and therapeutics quality | The rapid design and development of mRNA-based vaccines for the COVID-19 pandemic brought mRNA technology to the forefront of medical... | [Link] | On-Demand Registration Required | Global | Varies |
| 3053 | mRNA Vaccines Series: CMC and Analytics | The development and approval of mRNA-based vaccines for COVID-19 revealed the potential of this platform for both preventative and therapeutic... | [Link] | On-Demand Registration Required | Global | Varies |
| 3052 | mRNA Vaccines Series: Principles and Production | This webinar will cover general principles and modes of action for mRNA vaccines. It will also cover the production process... | [Link] | On-Demand Registration Required | Global | Varies |
| 3051 | USP Raw Material Standards to Support Quality of Pegylated Therapeutics | This course will introduce the use of polyethylene glycol (PEG) as a raw material used for conjugation with biologic molecules.... | [Link] | On-Demand Registration Required | Global | Varies |
| 3050 | Opportunities and Challenges in Raw Material and Starting Material Qualification for Cell and Gene Therapy Products | Understanding and controlling raw material variability requires a risk-based approach through the lens of deep technical experience and knowledge. For... | [Link] | On-Demand Registration Required | Global | Varies |
| 3049 | Raw Materials Quality: Requirements, Limitations, and Recommendations (from an Ancillary Material Manufacturer’s Perspective) | As Ancillary Materials (AM) supplier of cytokines and media we are reflecting on current requirements for AM quality systems and... | [Link] | On-Demand Registration Required | Global | Varies |
| 3048 | Strategy to Determine Impact of Complex Raw Material Variability on Process Performance | Raw materials, in particular cell culture media, represent a significant source of variability to biopharmaceutical manufacturing processes that can detrimentally... | [Link] | On-Demand Registration Required | Global | Varies |
| 3047 | Practical Considerations for Gamma Irradiation of Serum | Quality and safety of animal origin components used in the biologics manufacture is of the paramount importance in assuring quality... | [Link] | On-Demand Registration Required | Global | Varies |
| 3046 | Impact of Elemental Impurities in Biologics development and Manufacturing & Risk Management for Control Measures | Trace elements have significant biological relevance and can impact key performance and quality attributes of biological processes. This presentation will... | [Link] | On-Demand Registration Required | Global | Varies |
| 3045 | A Combination of Strategic Planning and Technical Assessment to Overcome Raw Material Management Challenges | In Biologics Therapeutics Manufacturing, an appropriate raw material management strategy in a systematic manner is a key factor to ensure... | [Link] | On-Demand Registration Required | Global | Varies |
| 3044 | An Attribute Focused Approach to Identify and Control Raw Material Variability | Raw materials are a fundamental element in the manufacturing of biopharmaceuticals that can impact the performance of the manufacturing process... | [Link] | On-Demand Registration Required | Global | Varies |
| 3043 | Viral Safety of Raw Materials Used in Production of ATMPs | Fetal Bovine Serum is commonly used at cell culture supplement for production of vaccines and viral gene transfer vectors. However,... | [Link] | On-Demand Registration Required | Global | Varies |
| 3042 | Advanced Raw Material Control: Rapid ID and Raw Material Informatics | Advanced raw material control appropriately identifies risk, deploys limited resources to manage this risk, and increases upstream supply chain flexibility... | [Link] | On-Demand Registration Required | Global | Varies |
| 3041 | Applying Online Analytical Tools to Characterize Cell Culture Medium Preparation | Variability in cell culture media can directly affect the biotherapeutic manufacturing process performance and drug substance quality. This variability is... | [Link] | On-Demand Registration Required | Global | Varies |
| 3040 | Analytical Aspects of Control and Characterization: Polysorbate Case Study | Polysorbates (mainly PS20 and PS80) are critical excipients in (bio-)pharmaceutical formulations that protect the contained therapeutic proteins from interfacial stress.... | [Link] | On-Demand Registration Required | Global | Varies |
| 3039 | New Understanding Relating to Existing Excipients and Formulation Approaches | As part of USPs work to strengthen the Polysorbate monographs, the USP Excipients Expert Committee is evaluating technologies and methods... | [Link] | On-Demand Registration Required | Global | Varies |
| 3038 | Quality Considerations for Critical Materials in Gene-Based Therapies | A number of gene-based cell therapies are in development with several products already in commercial phase. Human primary cells and... | [Link] | On-Demand Registration Required | Global | Varies |
| 3037 | Raw Material Controls for Biologics: Inspectional Experience | Control of materials is critical to ensure manufacturing consistency, resulting safety, quality and effectiveness of a product, and ultimately its... | [Link] | On-Demand Registration Required | Global | Varies |
| 3036 | Regulatory Considerations for Raw Material Qualification and Related Controls for Biotechnology Drugs | This course covers: *Background on raw materials as a critical component of good manufacturing practices *Types of raw materials -... | [Link] | On-Demand Registration Required | Global | Varies |
| 3035 | Qualification of Raw Materials Used in the Manufacturing of Cellular Therapies | Qualification of raw materials used in the manufacturing of cellular therapies requires the use of risk assessment strategies to categorize... | [Link] | On-Demand Registration Required | Global | Varies |
| 3034 | Biosimilars: Meeting the FDA with Your Biosimilar Product | In the rapidly evolving biosimilar landscape, regulatory approval remains a critical challenge for manufacturers seeking to bring these complex products... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3033 | Modern Approaches to mRNA Manufacturing | mRNA market in 2021 grew exponentially due to the success of COVID-19 vaccines by BioNTech, Johnson and Johnson and Moderna.... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3032 | Cost Savings Related to Qualifying Cell & Gene Therapy Facilities | Viral vector and cell/gene therapy facilities can be less complicated and require fewer critical utilities when compared to pharmaceutical or... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3031 | Immunogenicity Risk Assessment of Peptide Drugs and their Impurities | The US generic peptide drug market is valued at $62 billion USD in 2023 and is expected to increase in... | [Link] | On-Demand Registration Required | Global | Varies |
| 3030 | Process improvements to effect more efficient and greener peptide synthesis | For synthesis of peptides, conventional approach utilizes linear solid phase peptide synthesis (SPPS) that is known to produce Des impurities,... | [Link] | On-Demand Registration Required | Global | Varies |
| 3029 | LC-HRMS-based Multi-attribute Method for Oligonucleotides (MAMO): Characterization and Impurity Profiling | A significant challenge in the development, manufacturing, and regulatory evaluation of both new and generic synthetic oligonucleotide drugs is the... | [Link] | On-Demand Registration Required | Global | Varies |
| 3028 | Improving TIDES product risk assurance with NMR spectroscopy | The wealth of structural information that accompanies NMR spectroscopy has made it instrumental for traditional small molecules medicinal and analytical... | [Link] | On-Demand Registration Required | Global | Varies |
| 3027 | Synthetic Oligonucleotide Impurity Analysis: Enhancing the Conventional Single Quad Method Using UPLC-ToF-MS | As synthetic oligonucleotide therapeutics gain increasing interest for drug products, having efficient methods for determining their impurity profiles is critical,... | [Link] | On-Demand Registration Required | Global | Varies |
| 3026 | Analytical toolbox to enable the synthesis and release of complex synthetic peptides | Peptides are gaining tremendous importance as modern drug substances. Addressing the urge for chemically complex high-quality drugs, cutting edge approaches... | [Link] | On-Demand Registration Required | Global | Varies |
| 3025 | Holistic control strategy of oligonucleotides starting materials | In the synthesis of oligonucleotides, the control strategy of starting materials is essential to guarantee manufacturing process reliability and API... | [Link] | On-Demand Registration Required | Global | Varies |
| 3024 | Framework for Evaluating Impurity Risks in Starting Materials for Oligonucleotide API Manufacturing | In the oligonucleotide therapeutics industry, the purity of active pharmaceutical ingredients (API) is paramount. Impurities in starting materials (SM) can... | [Link] | On-Demand Registration Required | Global | Varies |
| 3023 | CMC Regulatory Experiences and Expectations for Peptides | The diversity and complexity of peptide therapeutics pose challenges for the characterization and impurity control of such medicines. This presentation... | [Link] | On-Demand Registration Required | Global | Varies |
| 3022 | CMC Challenges in FDA-approved Synthetic Oligonucleotide Drugs | Oligonucleotide drugs are a special class of therapeutics that are not explicitly covered by the regulatory and CMC guidance which... | [Link] | On-Demand Registration Required | Global | Varies |
| 3021 | USP Standards to Support Quality of Peptide and Oligonucleotide Therapeutics | This webinar provides an overview of USP documentary and physical reference standards to support therapeutic peptides. It introduces USP existing... | [Link] | On-Demand Registration Required | Global | Varies |
| 3020 | Novel Approaches for Mass Spectrometry Characterization of Highly Modified Synthetic RNA | Over the last years, the demand of MS based structural characterization approaches in quality control of oligonucleotide based pharmaceuticals increased... | [Link] | On-Demand Registration Required | Global | Varies |
| 3019 | Developing Product-specific Guidances on Oligonucleotides for Generic Drug Development | Synthetic oligonucleotides are short nucleic acid chains produced by chemical synthesis that can control gene expression in a sequence specific... | [Link] | On-Demand Registration Required | Global | Varies |
| 3018 | Characterization of Low-level D-Amino Acid Degradation Impurities Using Liquid Chromatography-High Resolution Tandom Mass Spectrometry | Introduction. Trace amount of impurity may influence the efficacy and safety of the pharmaceuticals, which requires comprehensive analysis of the... | [Link] | On-Demand Registration Required | Global | Varies |
| 3017 | In-depth Impurity Profiling of Synthetic Oligonucleotides by High Resolution Mass Spectrometry | One of the primary challenges in synthetic oligonucleotide drug development and application review is the imprecision of commonly used analytical... | [Link] | On-Demand Registration Required | Global | Varies |
| 3016 | Risk Assessment for a Nitrosamine Contamination of Peptide APIs Manufactured by Solid-Phase Peptide Synthesis (SPPS) | Due to findings of nitrosamines in multiple medicines since July 2018, both the FDA and the EMA published guiding documents... | [Link] | On-Demand Registration Required | Global | Varies |
| 3015 | Current CMC Regulatory Experiences and Expectations for Oligonucleotides | This presentation will provide an overview about the regulatory landscape for oligonucleotides. Issues related to the pharmaceutical quality of oligonucleotides... | [Link] | On-Demand Registration Required | Global | Varies |
| 3014 | Quantitation of Impurities in Tirzepatide Peptide Fragments by High Resolution Ultra-High Pressure Liquid Chromatography-Mass Spectrometry (UHPLC-MS) | Tirzepatide is a novel 39 amino acid residue GIP (gastric inhibitory polypeptide) and GLP-1 (glucagon-like peptide-1) dual receptor agonist targeted... | [Link] | On-Demand Registration Required | Global | Varies |
| 3013 | Analytical Strategies for Characterization of Stereopure Platform Chemistry | Traditional phosphorothioate oligonucleotide synthesis methods generate stereoisomeric mixtures composed of thousands of PS-modified molecules. Wave Life Sciences is pioneering the... | [Link] | On-Demand Registration Required | Global | Varies |
| 3012 | Analytical Method Development for Critical Impurities in Phosphoramidites | An overview of various analytical approaches for the detection, identification, and control of critical impurities in phosphoramidites will be presented... | [Link] | On-Demand Registration Required | Global | Varies |
| 3011 | Fmoc Alpha Methyl Quaternary Amino Acid Supply Chain Development | The implementation of Non-Coded amino acids to improve stability and function in therapeutic peptides is an active area of research.... | [Link] | On-Demand Registration Required | Global | Varies |
| 3010 | Strategies for the Control of Impurities in Oligonucleotide Synthesis | Solid-phase synthesis is predominantly used today for the manufacture of oligonucleotide therapeutics. Impurities in the oligonucleotide API need to be... | [Link] | On-Demand Registration Required | Global | Varies |
| 3009 | Evaluation of Chromatographic Techniques for Oligonucleotide Separation and Subsequent Detection by HRMS for Routine Testing | Standard approaches to LC separation of oligonucleotides include an ion pair, an acid modifier and a C18 column. Attempts have... | [Link] | On-Demand Registration Required | Global | Varies |
| 3008 | CMC Regulatory Considerations for Oligonucleotides and Peptides: Similarities and Differences | This presentation will provide an overview what can oligonucleotide and peptide developers learn from each other in their regulatory experiences,... | [Link] | On-Demand Registration Required | Global | Varies |
| 3007 | Applications of Green Chemistry in Oligonucleotide Manufacturing | Processes that provide economical, safe, and green access to chemically modified oligonucleotides is of paramount importance in the manufacturing of... | [Link] | On-Demand Registration Required | Global | Varies |
| 3006 | Application of NMR Spectroscopy for Characterization and Identity Testing of Oligonucleotide Drug Molecules | With recent introduction of several new Oligonucleotide based drugs to the market, an increased need for high quality analytics to... | [Link] | On-Demand Registration Required | Global | Varies |
| 3005 | Method Development for the Characterization of Synthetic Oligonucleotides by LC-MS | The primary method for quantitation and characterization of synthetic oligonucleotides is ion-pair reversed phase liquid chromatography (IP-RPLC). Mobile phase composition... | [Link] | On-Demand Registration Required | Global | Varies |
| 3004 | Drug Delivery Systems and Life Cycle Management for Peptides Beyond the Vial and Syringe | There are an abundant number of examples of commercial peptides in lyophilized powder or aqueous solution format and some peptides... | [Link] | On-Demand Registration Required | Global | Varies |
| 3003 | CMC and Regulatory Challenges for Oligonucleotide Drugs | Oligonucleotide drugs are a special class of therapeutics that are not explicitly cover by the regulatory and CMC guidances that... | [Link] | On-Demand Registration Required | Global | Varies |
| 3002 | Vendor Selection for Unusual Amino Acid Derivatives | Starting material quality is critical for the final API quality. For the synthesis of therapeutic peptides, the normal proteinogenic Fmoc... | [Link] | On-Demand Registration Required | Global | Varies |
| 3001 | Considerations of Comparative Studies for Complex Synthetic Peptide Products | During the development of complex generic peptide products, the amount of comparative studies required by the FDA have been on... | [Link] | On-Demand Registration Required | Global | Varies |
| 3000 | Antisense Oligonucleotide Specification and Release Tests using a Risk-Based Platform Approach | The establishment of appropriate specifications and release tests for drug substance and product is a crucial part of an analytical... | [Link] | On-Demand Registration Required | Global | Varies |
| 2999 | Synthesis of Tirzepatide by Native Chemical Ligation (NCL), a Once-weekly dual GIP and GLP-1 Receptor Agonist | Tirzepatide, a 39-amino acid synthetic peptide, is a once-weekly novel dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like-peptide-1) receptor agonist.... | [Link] | On-Demand Registration Required | Global | Varies |
| 2998 | Regulatory Considerations for Setting Smart Starting Material Specifications | Starting material specifications are a key element of the overall control strategy for synthetic oligonucleotides. In this presentation, we share... | [Link] | On-Demand Registration Required | Global | Varies |
| 2997 | Terminal Sterilisation of Oligonucleotide Drug Products | Terminal sterilisation is the process whereby a product is sterilised in its final container. This sterilisation process has always been... | [Link] | On-Demand Registration Required | Global | Varies |
| 2995 | Quality considerations for plasmid DNA as a starting material for cell and gene therapies | There is a need for more guidance regarding plasmid DNA used in the manufacturing of cell and gene therapy processes,... | [Link] | On-Demand Registration Required | Global | Varies |
| 2994 | Characterization and Biological Relevance of Protein Aggregates and Other Particles 100 20,000 nm in Size (Sub Micron and Subvisible) | Analysis of subvisible and visible particles—including foreign particles, protein aggregates from the API in biologics, microbubbles, and silicon oil droplets—is... | [Link] | On-Demand Registration Required | Global | Varies |
| 2993 | What’s New in Biologics? Analysis of Heparin Sodium Porcine and Bovine | Heparin sodium is an important anticoagulant with many indications, use in blood transfusions and dialysis procedures and the treatment of... | [Link] | On-Demand Registration Required | Global | Varies |
| 2992 | What’s New in Biologics? Potency Assays to Evaluate Coagulation Factor VIII and Factor IX | Hemophilia is a severe disorder caused by insufficient clotting proteins. Deficiencies in two of these proteins, coagulation factors VIII or... | [Link] | On-Demand Registration Required | Global | Varies |
| 2991 | What’s New in Biologics? Standards to Support Advanced Therapies | About 20 years ago, USP began supporting development and quality assessments of cell, gene and tissue-engineered products by producing a... | [Link] | On-Demand Registration Required | Global | Varies |
| 2990 | What’s New in Biologics? Focus on USP’s Vaccine Initiatives | Along with clean water and sanitation, vaccines are one of the most effective tools to support global public health. Since... | [Link] | On-Demand Registration Required | Global | Varies |
| 2989 | What's New in Biologics? Focus on USP’s Monoclonal Antibody Reference Standards | Many therapeutic monoclonal antibodies (mAbs) have been licensed or are in development to treat a wide variety of diseases, including... | [Link] | On-Demand Registration Required | Global | Varies |
| 2986 | Best Practices for Mass Spectrometry-Based Multi-Attribute Method (MAM) for Therapeutic Proteins USP General Chapter 1060 | Multi-Attribute Method (MAM) for analytical testing of biotherapeutics is gaining traction due to its potential to improve efficiency and provide... | [Link] | On-Demand Registration Required | Global | Varies |
| 2985 | Development and Characterization of Monoclonal Antibody Therapeutics | Many therapeutic monoclonal antibodies (mAbs) have been licensed or are in development to treat a wide variety of diseases, including... | [Link] | On-Demand Registration Required | Global | Varies |
| 2984 | Best Practices for Residual Host Cell Protein Measurement in Biopharmaceuticals by Mass Spectrometry: USP Chapter | Protein-based biotherapeutics are produced by numerous prokaryotic and eukaryotic cellular expression systems. During the manufacture of these products, host cell... | [Link] | On-Demand Registration Required | Global | Varies |
| 2983 | Regulatory and WHO Prequalification Considerations for Vaccines | This course will address the process for World Health Organization prequalification of vaccines. Participants will better understand the laboratory information... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 2982 | Quality Control of Vaccines Manufacturing | This course provides best practices for bioanalytical and analytical laboratories that support the quality control of vaccines. The course offers... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 2981 | Production of Vaccines and Sterile Biologics | This twelve-hour course will provide International Council for Harmonization (ICH) and World Health Organization (WHO) guidelines related to vaccine manufacturing... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 2980 | Cell Banking for Manufacturing of Vaccines | This course will provide International Council for Harmonization , World Health Organization, and USP guidelines related to cell banking and... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 2979 | Introduction to GMP Manufacturing and Characterization of Vaccines for Human Use | This course provides a general overview of manufacturing and characterization of vaccines including vaccine types, components, and functions. Fundamental concepts... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 2978 | Viral Vector Manufacturing and Control Strategies | Viral gene transfer vector manufacturing for in vivo and ex vivo applications has largely been in support of early phase... | [Link] | On-Demand Registration Required | Global | Varies |
| 2977 | USP-APEC: Virtual Training Workshop on Chemistry, Manufacturing and Control Challenges in CAR T Cell Therapy | The USP-APEC Center of Excellence for Advanced Therapies Virtual Training will convene regulators from APEC member economies to build regulatory... | [Link] | On-Demand Registration Required | Global | Varies |
| 2976 | Development and Validation of Bioassays for Advanced Therapies Workshop | USP is an Asia-Pacific Economic Cooperation (APEC) Center of Excellence for the Advanced Therapies priority work area. This priority work... | [Link] | On-Demand Registration Required | Global | Varies |
| 2968 | USP Antibiotic Compendial Standards and Modernization Approaches | Ensuring the quality of antibiotics is more important than ever as additional data shows that quality plays a role in... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 2967 | ATCC-USP Joint Webinar: Residual DNA Testing | Residual DNA testing is required for demonstrating clearance of DNA from the cell substrate used to manufacture biologics for therapeutic... | [Link] | On-Demand Registration Required | Global | Varies |
| 2966 | USP Standards that Support the Development and Characterization of Biologics | This webinar describes some of the USP standards published as chapters in the United States Pharmacopeia – National Formulary (USP–NF).... | [Link] | On-Demand Registration Required | Global | Varies |
| 2965 | Residual DNA Testing | Residual DNA testing is required for demonstrating clearance of DNA from the cell substrate used to manufacture biologics for therapeutic... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 2964 | USP Standards to Support the Characterization of mAbs: Applications and General Chapter | USP offers solutions to evaluate the quality attributes of monoclonal antibodies (mAbs) for therapeutic use. The validated methods that are... | [Link] | On-Demand Registration Required | Global | Varies |
| 2963 | Quantifying Host Cell Proteins by LC-MS: Experimental Demonstration and Method Comparison in USP 1132.1 | While no specific limits exist in regulatory guidance for Host Cell Proteins (HCPs), according to ICH Q6B specifications, HCP impurities... | [Link] | On-Demand Registration Required | Global | Varies |
| 2962 | Assays to Evaluate Fragment Crystallizable (Fc)-Mediated Effector Function | Fc effector function activities are mediated via interaction of the fragment antigen binding (Fab) domain of a therapeutic monoclonal antibody... | [Link] | On-Demand Registration Required | Global | Varies |
| 2960 | USP Standards and Best Practices for Gene Therapy | Gene therapies offer tremendous promise to address human disease but their complexity and diversity present unique challenges to those seeking... | [Link] | On-Demand Registration Required | Global | Varies |
| 2959 | Bioassay Design, Development and Validation | This bioassay course will focus on factors to be considered in the design, development and validation of bioassays. The course... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 2958 | Evaluation Strategy for Trace Elements in Cell Culture Media Used in the Manufacture of Recombinant Proteins | This webinar will discuss the new USP General Chapter Evaluation Strategy for Trace Elements in Cell Culture Media Used in... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 1851 | Pharmacovigilance (Level 3) | Purpose: To develop advanced expertise in pharmacovigilance science, risk assessment, and regulatory oversight, enabling experienced evaluators to lead complex safety... | [Link] | Registration Required | Africa, South Africa | Free |
| 1872 | Pharmacovigilance (Level 2) | Purpose: To develop applied competence in the evaluation, analysis, and management of pharmacovigilance data to support regulatory review and post-marketing... | [Link] | Registration Required | Africa, South Africa | Free |
| 1873 | Pharmacovigilance (Level 1) | Purpose: To introduce regulatory staff, healthcare professionals, and industry personnel to the fundamental principles of pharmacovigilance (PV) and the importance... | [Link] | Registration Required | Africa, South Africa | Free |
| 1857 | Good Manufacturing Practice - GMP (Level 1) | Purpose: To introduce regulatory officers, inspectors-in-training, and quality professionals to the fundamental principles and objectives of Good Manufacturing Practice (GMP)... | [Link] | Registration Required | Africa, South Africa | Free |
| 1856 | Good Manufacturing Practice - GMP (Level 2) | Purpose: To develop practical competence in the application of GMP principles through inspection planning, execution, and reporting.This level equips learners... | [Link] | Registration Required | Africa, South Africa | Free |
| 1852 | Good Manufacturing Practice - GMP (Level 3) | Purpose: To develop advanced inspectional, analytical, and regulatory decision-making expertise for senior inspectors and GMP specialists responsible for oversight of... | [Link] | Registration Required | Africa, South Africa | Free |
| 1847 | Clinical Trials (Level 2) | Purpose: To develop intermediate competence in the regulatory evaluation, monitoring, and management of clinical trials, focusing on practical application of... | [Link] | Registration Required | Africa, South Africa | Free |
| 1844 | Clinical Trials (Level 1) | Purpose: To introduce regulatory professionals, investigators, and stakeholders to the fundamental principles and regulatory requirements governing the conduct of clinical... | [Link] | Registration Required | Africa, South Africa | Free |
| 1841 | Clinical Evaluation of regulatory dossiers (Level 3) | Purpose: To develop advanced expertise in clinical data assessment and regulatory decision-making for complex products and innovative therapies.This level equips... | [Link] | Registration Required | Africa, South Africa | Free |
| 1838 | Clinical Evaluation of regulatory dossiers (Level 2 _ Additional) | [Link] | Registration Required | Africa, South Africa | Free | |
| 1835 | Clinical Evaluation of Regulatory Dossiers (Level 1 & 2) | Purpose: To introduce regulatory professionals to the fundamental principles, processes, and ethical considerations underpinning clinical evaluations in medicine regulation.This level... | [Link] | Registration Required | Africa, South Africa | Free |
| 1832 | Biostatistics (Level 2) | Purpose: To build applied competence in the use of biostatistical methods for the design, analysis, and interpretation of data from... | [Link] | Registration Required | Africa, South Africa | Free |
| 1829 | Biostatistics for regulators (Level 1) | Purpose: To introduce regulatory professionals to the fundamental principles of biostatistics and their application in the evaluation of medicines and... | [Link] | Registration Required | Africa, South Africa | Free |
| 1825 | BA-BE (Level 3) | Purpose : To develop advanced analytical and regulatory evaluation skills for in-depth assessment and decision-making in bioavailability and bioequivalence studies,... | [Link] | Registration Required | Africa, South Africa | Free |
| 1812 | Regulation of Biotherapeutics & Vaccines (Level 2) | Purpose: To provide regulatory professionals with a comprehensive foundational understanding of the science, development, and regulatory principles governing biotherapeutics and... | [Link] | Registration Required | Africa, South Africa | Free |
| 1815 | Regulation of Biotherapeutics & Vaccines (Level 3) | Purpose: To equip regulatory scientists and evaluators with advanced technical and regulatory skills required for in-depth assessment and decision-making regarding... | [Link] | Registration Required | Africa, South Africa | Free |
| 1818 | BA-BE (Level 1 and 2) | Purpose: To build foundational and intermediate competence in the principles, design, and regulatory evaluation of bioavailability and bioequivalence studies for... | [Link] | Registration Required | Africa, South Africa | Free |
| 1769 | Excellence in Pharmacovigilance: GVP Modules I to XVI | Organized and delivered in collaboration with the Dutch Medicines Evaluation Board (MEB), this face-to-face interactive training course covers the major... | [Link] | Europe | Paid | |
| 1770 | Quality Management Systems (QMS) in Medical Devices | The Quality Management in Medical Devices Training Course provides comprehensive insights into the internationally recognized standard for quality management systems... | [Link] | Paid | ||
| 1771 | Lead Auditor - Medical devices | This course develops competency in quality management systems auditing for medical devices, aligning with ISO 13485 and global regulatory expectations.... | [Link] | Instructor-led Registration Required | Paid | |
| 1768 | Foundations of Good Manufacturing Practices – USP | Pharmaceutical manufacturers must comply with the regulatory requirements of the countries where they produce and sell medical products. This free,... | [Link] | Certification Available Registration Required Self-paced | Free | |
| 1755 | USP Education Regulatory System Strengthening Catalog | More that 250 self-paced offerings available for free to medicine regulatory authorities and manufacturers in Africa through 2026. To support... | [Link] | Certification Available Registration Required | Global | Free, Paid, Discount for LMICs |
| 1754 | Animal Testing Replacement For Vaccines, A One Health View: Global Outlook And Future Strategy | The Humane World for Animals and IABS have been collaborating together since the 2019 IABS conference “Animal Testing for Vaccines Implementing... | [Link] | Registration Required | Global | Varies, Discount for LMICs |
| 1708 | WHO Academy | Discover a vast collection of high-quality courses on essential health topics. The WHO Academy provides top-tier courses designed by learning... | [Link] | Available in other languages Registration Required Self-paced | Global | Free |
| 1587 | EudraVigilance: Training and Support | EMA’s training hub for EudraVigilance, including EVWEB/electronic reporting, GVP Module VI alignment, and user support. | [Link] | Registration Required | Europe | Varies |
| 1535 | FDA/C-Path Institute Model Informed Drug Development Web-Based Training | The U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) Quantitative Medicine Center of Excellence (QM... | [Link] | Self-paced | Global | Free |
| 1550 | Case series causality assessment | UMC instructor-led online course on assessing causality for a group of ICSRs with the same medicine/event; practical group exercises for... | [Link] | Instructor-led | Global | Free |
| 1551 | Quantitative signal detection using VigiLyze | UMC instructor-led online course on quantitative signal detection with practical exercises using VigiLyze; suited to national PV centres and assessors. | [Link] | Instructor-led | Global | Free |
| 1588 | Clinical Trials Information System (CTIS): Training & Support | EMA’s CTIS training (modules, webinars and DIA sponsor end‑user training) to support compliance with EU CTR. EMA offers live training sessions to provide additional... | [Link] | Instructor-led Self-paced | Europe | Varies |
| 1590 | A Primer for Clinical Assessors within African Regulatory Agencies (Self-Paced) | Welcome to this self-paced / self-study version of “A Primer for Clinical Assessors within African Regulatory Agencies” course! These training... | [Link] | Registration Required Self-paced | Global | Free |
| 1601 | Clinical Data: Safety, Risk Management and Mitigation (Clinical Assessor Course - Self Paced) | This training examines how clinical data underpin safety evaluation, risk management, and mitigation throughout a product’s life cycle. It covers... | [Link] | Registration Required Self-paced | Africa | Free |
| 1600 | Critical Review of Clinical Data for Efficacy and Safety (Clinical Assessor Course - Self Paced) | This training focuses on critically reviewing clinical data for efficacy and safety, applying evidence-based practice principles to regulatory assessment. It... | [Link] | Registration Required Self-paced | Africa | Free |
| 1599 | Clinical data clinical endpoints and outcomes (Clinical Assessor Course - Self Paced) | This training introduces the principles of clinical endpoints, surrogates, and biomarkers, exploring how they relate to therapeutic indications and labeling.... | [Link] | Registration Required Self-paced | Africa | Free |
| 1598 | Assessment of Validity and Acceptability of Clinical Data for Regulation (Clinical Assessor Course - Self Paced) | This training covers how regulators judge the validity and acceptability of clinical data for decisions. It uses CTD Module 5... | [Link] | Registration Required Self-paced | Africa | Free |
| 1597 | Regulatory Assessment of Relevance of Clinical Data for Indication, Licence and Label (Clinical Assessor Course - Self Paced) | This training focuses on assessing clinical data for therapeutic indication, licence, and labeling. Topics include structured benefit–risk assessment, consistency with... | [Link] | Registration Required Self-paced | Africa | Free |
| 1596 | Interpretation and Reporting of Clinical Data (Clinical Assessor Course - Self Paced) | This lesson covers how clinical trial data is interpreted and reported: statistical hypotheses, efficacy and safety outcomes, estimands and intercurrent... | [Link] | Registration Required Self-paced | Africa | Free |
| 1595 | Collection of Clinical Data – What and How (Clinical Assessor Course - Self Paced) | This lesson outlines what clinical data is collected and how: trial phases, data types and validation, endpoint development, and the... | [Link] | Registration Required Self-paced | Free | |
| 1594 | Clinical Data for Regulation and Product Licensing (Clinical Assessor Course - Self Paced) | This course introduces the regulatory use of clinical data in product development and licensing. It examines how clinical trial and... | [Link] | Registration Required Self-paced | Africa | Free |
| 1593 | Molecule to Market - Overview of Drug Discovery & Development (Clinical Assessor Course - Self Paced) | This course provides an overview of the drug discovery and development process, from identifying unmet medical needs to selecting clinical... | [Link] | Registration Required Self-paced | Africa | Free |
| 1602 | Marketing Authorisation and Product Information (Clinical Assessor Course - Self Paced) | This training addresses marketing authorisation and product information: how clinical evidence is reflected in SmPCs and patient leaflets, and how... | [Link] | Registration Required Self-paced | Africa | Free |
| 1603 | Clinical Data for Regulatory Communications (Clinical Assessor Course - Self Paced) | This training outlines how clinical data are communicated to regulators, clinicians, sponsors, and patients during and after marketing authorisation. It... | [Link] | Registration Required Self-paced | Africa | Free |
| 1604 | Regulators and Sponsors as Partners for Patient Benefit (Clinical Assessor Course - Self Paced) | This training examines how regulators and sponsors work together across the product life cycle. It covers drivers on both sides,... | [Link] | Registration Required Self-paced | Africa | Free |
| 1605 | Biosimilars (Clinical Assessor Course - Self Paced) | This training covers core concepts and regulatory frameworks for biosimilars (EMA, FDA, WHO), clinical and PK study design, case studies... | [Link] | Registration Required Self-paced | Africa | Free |
| 1606 | Regulation of Biotherapeutics and Vaccines (Level 1) | The aim of this short learning programme is to introduce course participants to the theory and practice of conducting regulatory... | [Link] | Restricted to Internal Staff | Africa | Free |
| 1607 | EMA Information Day on Submission of Initial MA & Post-Marketing Applications | EMA-led training day on dossier submission, lifecycle & regulatory procedures | [Link] | Registration Required | Europe | Paid |
| 1608 | Extended EudraVigilance Medicinal Product Dictionary Training | Hands-on training on XEVMPD compliance & submission | [Link] | Registration Required | Europe | Paid |
| 1610 | EMA Clinical Trials Information System - Sponsor user training programme | Practical, hands-on training course on CTIS system functionalities including the creation and submission of an initial application, respond to RFIs,... | [Link] | Registration Required | Global | Paid |
| 1612 | Virtual Live Hands-On Training Course for Clinical Trials Sponsors Using The EudraVigilance System | Virtual live training course including EMA required knowledge evaluation, on how to report, view and download ICSRs using the EudraVigilance... | [Link] | Registration Required | Europe | Paid |
| 1613 | EMA Information Day on submission predictability of initial marketing authorisation | The focus of this interactive Information Day will be to enhance a common understanding, raise awareness of the challenges for... | [Link] | Registration Required | Europe | Paid |
| 1614 | eXtended EudraVigilance Medicinal Product Dictionary Training Course | Virtual training course on how to submit and retrieve medicinal product data using EVWEB/ XEVMPD (Art 57 database) for authorised... | [Link] | Registration Required | Europe | Paid |
| 1615 | Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System | Virtual live training course including EMA required knowledge evaluation, on how to report, view and download ICSRs using the EudraVigilance... | [Link] | Registration Required | Global | Paid |
| 1552 | FDA Clinical Investigator Training Course (CITC) | ABOUT THIS EVENT (Hosted by CDER SBIA) This is a recording (video, audio and slides) of the Annual FDA training... | [Link] | Self-paced | Americas, United States of America | Free |
| 1553 | Data Safety and Monitoring Boards (DSMBs) for Clinical Trials | This course outlines the role of a Data Safety and Monitoring Board (DSMB) during a clinical trial. Appointed by the... | [Link] | Available in other languages | Global | Free |
| 1554 | ICH Good Clinical Practice E6(R3) | Updated GCP course aligned to ICH E6(R3); 8 modules with certificate; relevant for regulators overseeing trials. | [Link] | Available in other languages Self-paced | Global | Free |
| 1536 | Pharmacovigilance (Level 1) | Pharmacovigilance is often considered to be an area of specialization not adequately covered in undergraduate curricula for the purpose of... | [Link] | Restricted to Internal Staff | Africa, South Africa | |
| 1537 | International Conference on Pharmacometrics (ICoP India 2026) | The second annual conference of the Society of Pharmacometrics and Health Analytics (formerly PAGIN), organized by the Centre for Pharmacometrics,... | [Link] | Asia, India | Paid, Scholarships Available | |
| 1517 | Certificate Course on Bioequivalence Analysis in Drug Development | Objectives: This certificate program offers a practical and comprehensive introduction to bioequivalence (BE) analysis in drug development. Designed for professionals... | [Link] | Certification Available Instructor-led Registration Required | Global, India | Paid |
| 1518 | Certificate Course on AI in Drug Development | Objectives Understand the fundamental concepts of machine learning and their applications in drug development use cases. Understand and apply machine... | [Link] | Certification Available Instructor-led Registration Required | Global, India | Paid |
| 1511 | Building and Implementing PBPK Models Webinar | Wednesday, 25 June 202514:00 West African Time Agenda: Verification and Validation of PBPK Models (Part 2) Questions and Answers from... | [Link] | Instructor-led Registration Required | Africa, Nigeria | Free |
| 1498 | Seventh Biennial Scientific Conference on Medical Products Regulation in Africa (SCoMRA VII) | The Scientific Conference on Medical Product Regulation in Africa (SCoMRA) 2025 will be convened under the theme: “Regulatory Harmonisation: “Unlocking... | [Link] | Registration Required | Africa | |
| 1487 | Fundamentals of Physiologically Based Pharmacokinetic (PBPK) Modelling | Last month, we had an introduction to pharmacometrics. Join us as we continue our discussion on PBPK modelling. This webinar... | [Link] | Instructor-led Registration Required | Global | Free |
| 1484 | Exploring the fundamentals of PBPK and Population Pharmacokinetics | PMX Africa: Nigeria ChapterMarch 2025 Webinar Introduction to PBPK and Population PharmacokineticsRecorded: Wednesday, March 26, 2025 This was an insightful... | [Link] | Self-paced | Global | Free |
| 1481 | Mechanistic Absorption Modelling: Enhancing Understanding and Prediction of Drug Performance | About this seriesSharing knowledge, presenting advances and discussing best practices in pharmacometrics, featuring locally-relevant case studies in application of PBPK... | [Link] | Global | Free | |
| 1477 | Digital Health Africa 2025 | The Digital Health Africa Conference (DHA-2024) has successfully showcased progress in digital health, telemedicine, precision medicine, real-world evidence, pharmacometrics and artificial intelligence... | [Link] | Registration Required | Africa | Varies, Discount for LMICs |
| 1251 | Nonlinear Mixed Effects Modeling with Pumas | Join the University of Cape Town chapter of Pharmacometrics Africa for a hands-on workshop focused on Nonlinear Mixed Effects Modeling Workflows... | [Link] | Instructor-led Registration Required | Africa, South Africa | Varies |
| 55 | Pharmacometric Considerations for Guiding Pediatric Trial Designs | Major gaps exist in the ability to appropriately design pediatric clinical trials as well as construct suitable dosing guidance in... | [Link] | Global | Free | |
| 56 | Controlled Human Infection Challenge Studies: Lessons from Malaria towards COVID-19 | Controlled Human Infection Challenge Studies involve the deliberate infection of healthy volunteers to support clinical vaccine development, for example for... | [Link] | Global | Free | |
| 54 | Clinical Pharmacology in Africa - history, progress and lessons learnt | Each year, Pharmacokinetics UK honors the memory of Peter Coates by inviting speakers that are recognized for their contributions to... | [Link] | Africa | Free | |
| 52 | Global Benchmarking Tool for Assessors | This training is developed for WHO assessors using the Global Benchmarking Tool (GBT) to benchmark Regulatory Authorities. In line with... | [Link] | Available in other languages Certification Available Registration Required Self-paced | Global | Free |
| 51 | Good Reliance Practices | The aim of this course is to provide an introduction to WHO Good Reliance Practices (GRelP) and to advocate for... | [Link] | Global | Free | |
| 50 | Vaccine Safety Basics | This course introduces participants to the foundations of vaccine pharmacovigilance. The aim of this course is to provide healthcare professionals... | [Link] | Available in other languages Registration Required Self-paced | Global | Free |
| 49 | Pharmacometrics Self-Paced | These lessons provide a structured overview of clinical pharmacology and pharmacometrics, and is part of a set of training activities... | [Link] | Free | ||
| 57 | Model-informed Drug Repurposing: Applications for COVID-19 | Examine the scientific basis for your COVID-19 study: The global scientific community’s scramble to rapidly find therapeutics for COVID-19 has... | [Link] | Free | ||
| 47 | Cross-Discipline Mathematical Modelling Symposium 2023 | A multidisciplinary discussion about the concepts and applications related to mathematical modelling and simulations. The structure of the event is... | [Link] | Free | ||
| 46 | Digital Health Africa Conference 2024 | This conference served as a platform to address the unique challenges Africans face and to capitalise on the opportunities for... | [Link] | Varies, Discount for LMICs | ||
| 45 | Advanced Pharmacometrics | Prof. Nick Holford has made his substantial (created over a 30+ year career) library of course materials available for public... | [Link] | Global | Free | |
| 44 | Pharmacometrics Training Library | As part of Metrum Institute's continuing efforts to support and grow the discipline of pharmacometrics, we are pleased to announce... | [Link] | Global | Varies | |
| 72 | Bioequivalence and Bioavailability Forum | This is a collection of materials related to bioequivalence set up by Helmut Schütz, a chemical engineer by training who... | [Link] | Global | Free | |
| 71 | The Global Health Network Resource Gateway | A library of hundreds of free and open access resources found across the whole of The Global Health Network. This... | [Link] | Global | Free | |
| 70 | Clinical Investigator Certificate Course (CLIC) | The planning, preparing, and organising of clinical trials have become a highly complex task that includes important issues such as:... | [Link] | Certification Available Instructor-led Registration Required | Africa | Varies |
| 69 | Clinical Assessors Regulatory Short Course | This 13-week University-certified virtual course addresses gaps in regulatory sciences through self-study and live tutorials by subject matter experts from academia,... | [Link] | Instructor-led Registration Required | Africa | Varies |
| 68 | Vienna School of Clinical Research - Short courses Clinical Research | Since its foundation in the year 2000 VSCR has focused on training and education in all relevant topics in Clinical... | [Link] | |||
| 67 | RAPS online university | The RAPS Online University offers certificate courses in two tracks—pharmaceuticals and medical devices. The Regulatory Affairs Certificate Program is an... | [Link] | Varies | ||
| 66 | EMA Training opportunities for non-EU regulators | The European Medicines Agency (EMA) supports non-European Union (EU) regulators by organising dedicated awareness sessions to provide them an insight into... | [Link] | Self-paced | Global | Free |
| 65 | PharmaTrain resource library | Abstract: PharmaTrain is a network of public and private partners that aim to develop and make available education and training... | [Link] | |||
| 64 | Building Capability for Clinical Pharmacology Research in Sub-Saharan Africa | Abstract: A strong scientific rationale exists for conducting clinical pharmacology studies in target populations because local factors such as genetics,... | [Link] | Global | Free | |
| 63 | Needs-driven talent and competency development for the next generation of regulatory scientists in Africa | Abstract: Capacity building programmes for African regulators should link education, training and research with career development in an approach that... | [Link] | |||
| 62 | Clinical Pharmacology Worldwide: A Global Health Perspective | Abstract: Capacity building programmes for African regulators should link education, training and research with career development in an approach that... | [Link] | Africa, Ghana, Global, South Africa, Zimbabwe | Free | |
| 61 | Pharmacometrics: opportunity for reducing disease burden in the developing world: the case of Africa | Abstract: Pharmacometricians are virtually nonexistent in Africa and the developing world. The unrelenting burden of infectious diseases, which are often... | [Link] | |||
| 60 | Non-Compartmental Analysis Webinar | The first step of any PK/PD data analysis is to look at the data on hand and generate insights. The... | [Link] | |||
| 58 | Malaria Vaccine Webinar – Pharmacometrics Africa launch | If we were to develop a second-generation malaria vaccine, what product qualities should be adjusted to improve protection?This webinar commences... | [Link] | |||
| 59 | Principles of ensuring data integrity | Have you ever lost data or have someone who worked on a project leave and take their knowledge of the... | [Link] |
| ID | Title | Description | Link | Resource Tags | Regions / Countries | Costs |
|---|---|---|---|---|---|---|
| 3532 | Principles of Clinical Pharmacology | This course is a free, online, asynchronous lecture series available to participants around the world. The course covers the fundamentals... | [Link] | Certification Available Registration Required | Free | |
| 3234 | USP-NF/PF Overview (Tutorial) | Learn how to navigate the USP–NF and PF information online. An overview of the system and answers to common questions,... | [Link] | On-Demand Registration Required | Global | Varies |
| 3233 | Introduction to USP's Pending Monograph Process (PMP) (Webinar & Q&A) | The Pending Monograph Process (PMP) is a successful collaboration developed between the USP and FDA to allow monograph revisions to... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3232 | USP SEPC: Changes to USP-NF Publication Model | In July of 2025, USP will be implementing changes to the USP publication schedule. This course details the Changes to... | [Link] | On-Demand Registration Required | Global | Varies |
| 3231 | Setting the Standard: USP’s Journey in Global Health | This course offers a comprehensive overview of the U.S. Pharmacopeia (USP), exploring its mission, organizational structure, and global influence in... | [Link] | eLearning Registration Required | Global | Varies |
| 3229 | The Medicines Risk-based Surveillance (MedRS) tool for post-marketing surveillance: Introductory overview of key features and use | The Medicines Risk-based Surveillance (MedRS) tool is a free web-based platform that automates the development of sampling protocols for post-marketing... | [Link] | On-Demand Registration Required | Global | Varies |
| 3228 | Medical Devices Standards and Classifications: Focus on Maternal Neonatal and Child Health (MNCH) | This course focuses on the regulation of medical devices and is self-paced. It is made up of three lessons: Lesson... | [Link] | eLearning Registration Required | Global | Varies |
| 3221 | Proposed Revision to USP Nuclear Magnetic Resonance Spectroscopy-Theory and Practice | The US Pharmacopeial Convention (USP) solicited public comments on the draft revision of USP General Chapter Nuclear Magnetic Resonance Spectroscopy-Theory... | [Link] | On-Demand Registration Required | Global | Varies |
| 3220 | Proposed Revision to USP Nuclear Magnetic Resonance Spectroscopy | The US Pharmacopeial Convention (USP) solicited public comments on the draft revision of USP General Chapter Nuclear Magnetic Resonance Spectroscopy... | [Link] | On-Demand Registration Required | Global | Varies |
| 3219 | Quantitative NMR Good Weighing Practices and Measurement Uncertainty | A key step in quantitative NMR (qNMR) testing is the weighing of standards and samples, as the accuracy of qNMR... | [Link] | On-Demand Registration Required | Global | Varies |
| 3218 | qNMR in Complex Drug Product Quality: From Benchtop to High-Resolution | qNMR is a versatile tool that can quickly and accurately identify and quantify chemical components of both complex and biological... | [Link] | On-Demand Registration Required | Global | Varies |
| 3217 | Pharmacopeial Applications of qNMR: A Selection of Vignettes | This presentation highlights four projects where NMR spectroscopy has been applied to solve analytical challenges over the years, each with... | [Link] | On-Demand Registration Required | Global | Varies |
| 3216 | Drug Quality Control Applications for qNMR | Quantitative nuclear magnetic resonance (qNMR) is a powerful tool for measuring drug content due to its high speed, sensitivity, and... | [Link] | On-Demand Registration Required | Global | Varies |
| 3215 | Development of a Reference-Free Quantification Method Using qNMR and Chromatography | Many reference materials for target analytes are not commercially available. This causes a problem in the regulatory or health authority... | [Link] | On-Demand Registration Required | Global | Varies |
| 3214 | qNMR under GxP—Automated End-to-End Solution | It is critical to comply with 21 CFR p11 and the principles of data integrity when working under GxP during... | [Link] | On-Demand Registration Required | Global | Varies |
| 3213 | Interlaboratory Comparison of Benchtop NMR Spectrometers | Due to its advantages of being a direct comparison method, quantitative NMR spectroscopy (qNMR) becomes increasingly popular in industry. While... | [Link] | On-Demand Registration Required | Global | Varies |
| 3212 | Proposed Revisions to USP General Chapters & | USP General Chapters and are currently being revised by an Expert Panel. Since the last revision in 2013, there has... | [Link] | On-Demand Registration Required | Global | Varies |
| 3211 | Compact NMR Spectroscopy for Automated Continuous-Flow Production of Chemicals and Pharmaceuticals | Chemical companies are under constant pressure to improve productivity while cutting costs. Flexible and modular chemical plants can produce high-quality... | [Link] | On-Demand Registration Required | Global | Varies |
| 3210 | Determining Purity with Benchtop 1H NMR | High-field NMR instruments are excellent at chemical structure elucidation and quantitation, but their size and complexity mean that these instruments... | [Link] | On-Demand Registration Required | Global | Varies |
| 3209 | Improving Accuracy of Benchtop qNMR for Samples with Protonated Solvents | Strong spectral signatures from typical protonated solvents in liquid formulations present challenges for the quantification of analytes by NMR. In... | [Link] | On-Demand Registration Required | Global | Varies |
| 3207 | USP Standards: Roles and Responsibilities for Pharmacy Leaders | This course of the education offering is meant for Pharmacy Leaders responsible for the understanding, support and implementation of USP... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3206 | USP Standards: Roles & Responsibilities for Institution Leaders | The USP Institution Solution is an eLearning, practice-centric, comprehensive training program that helps hospital staff meet quality and compliance expectations... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3205 | Interpreting USP Compounded Preparation Monographs in Compounding Practice | USP Compounded Preparation Monographs (CPMs) are published after extensive review and testing by the USP Compounding Expert Committee. While most... | [Link] | On-Demand Registration Required | Global | Varies |
| 3204 | eLearning: USP Hazardous Drugs—Handling in Healthcare Settings for Compounding Professionals | This 6.5-hour eLearning course, delivered through an innovative, interactive, online format, aims to improve your knowledge in the implementation of... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3203 | USP-NF General Chapter Hazardous Drugs - Handling in Healthcare Setting | This course discusses key requirements in USP General Chapter Hazardous Drugs—Handling in Healthcare Settings. The course will describe the standards... | [Link] | Classroom On-Demand Registration Required | Global | Varies |
| 3201 | eLearning: USP Pharmaceutical Compounding—Sterile Preparations for Compounding Professionals | This eLearning course, delivered through an innovative, interactive, online format, aims to improve your knowledge in the implementation of USP... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3200 | USP General Chapter Pharmaceutical Compounding - Sterile Preparations | This course aims to improve your knowledge in the implementation of USP General Chapter Pharmaceutical Compounding—Sterile Preparations. The course describes... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3199 | eLearning: USP Pharmaceutical Compounding—Nonsterile Preparations for Compounding Professionals | This eLearning course, delivered through an innovative, interactive, online format, aims to improve your knowledge in the implementation of USP... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3198 | USP General Chapter Pharmaceutical Compounding - Nonsterile Preparations | The course describes the scope of USP , outlines the responsibilities of compounders, defines the criteria for component selection and... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3197 | Labeling Requirements for Prescription Drugs, Updates, and Future Direction for Chapter | Medication misuse has resulted in more than 1 million adverse drug events per year in the United States. Patients’ best... | [Link] | On-Demand Registration Required | Global | Varies |
| 3196 | USP Pharmaceutical Calculations | This course will provide general information to assist pharmacists, pharmacy technicians, and pharmacy students in performing calculations for compounding and... | [Link] | eLearning Registration Required | Global | Varies |
| 3195 | Physical Environments that Promote Safe Medication Use | Work environment has been identified as one of the most common factors contributing to medication errors reported to USP. The... | [Link] | On-Demand Registration Required | Global | Varies |
| 3193 | Pharmaceutical Quality Practices: Change Control Management | This course introduces change control management . It will cover regulatory guidelines for change reporting. Subject area: cGMP Objectives (If... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3192 | Audit Fundamentals Theory | This course introduces the audit process, planning, data review, reporting and CAPA. Participants will experience applicable template based discussions on... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3191 | Deviation Investigations Including RCA | This course provides an overview of deviations, regulatory guidelines, investigation roles and responsibilities as well as stages of investigation. Investigation... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3190 | Corrective and Preventive Action (CAPA) | This course provides a brief overview of the CAPA life cycle, roles and responsibilities, implementation, verification, effectiveness check. Regulatory consequences... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3187 | From Experimental to Accepted: How In-Silico Modeling is Redefining CMC with Regulatory Confidence | This webinar explores the transformation of in-silico modeling from an experimental tool into a regulatory-accepted element of pharmaceutical Chemistry, Manufacturing,... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3186 | Cell & Gene Therapy, Manufacturing & Quality | The success of autologous CAR-T therapies such as Kymriah® and YESCARTA® marked a turning point in cell and gene therapy... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3185 | PCM-Continuous Manufacturing: Presenting Your Business Case | For drug innovators, CDMOs, Over the Counter (OTC), or generics manufacturers, knowing how and when to adopt pharmaceutical continuous manufacturing... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3184 | The Basic of a PCM Control Strategy: Material Characterization | Measurement tools and models give a deeper understanding of process behaviors, like viewing your process in a higher resolution. During... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3183 | EU Annex 1 in Full Effect: Are Manufacturers with EU Drug Product Prepared? | Annex 1 is an opportunity for industry to emphasize advanced technologies and for Pharma companies to speed up their processes... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3182 | PCM for Drug Substance (API) | Continuous processing is a viable alternative manufacturing method to batch production for small-molecule API. This webinar provides exploration of Pharmaceutical... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3181 | Entering the U.S. Markets: What Does it Take? | This webinar will address the most important steps in a roadmap to bring biosimilar, generic, and complex generic drugs through... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3180 | PCM and Regulatory: It's All About the Data | This webinar will guide you through the expctations of regulators when filling a Pharmaceurtical Continuous Manufacturing (PCM) process for an... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3179 | PCM and Quality: Upgrade Your Resolution | In process development of a Pharmaceutical Continuous Manufacturing (PCM) oral solid dose (OSD) drug product, the goal is to identify... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3178 | Modern Quality Techniques: Patient-centric Processes, Integrated QMS, Regulatory Intelligence | For an organization to move to and thrive in a culture of quality involves having consistent, reliable, robust business processes... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3177 | PCM Equipment Design: Bringing the Pieces Together | This webinar brings an overview of what the design elements of a PCM line look like, and how they work... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3176 | PCM: What is the Best Business Strategy for You? | As a company producing Oral Solid Dose drug product, how can Pharmaceutical Continuous Manufacturing (PCM) solve specific problems and help... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3175 | What You Need to Know About the EU GMP Annex 1 Revision | The final version of EU GMP Annex 1 is an opportunity for industry to apply solutions that emphasize advanced technologies... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3174 | Quality Considerations for a Robust Data Integrity Program | Quality, with its checks and balances, is the foundation and a key to success for your pharma startup. A proactive,... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3173 | Applying Process Analytical Technology (PAT) to Support Real Time Release (RTR) | PAT is an enabler for designing quality into a product when quality by design (QbD) principles are applied, with opportunities... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3172 | Quality Considerations for Aseptic Processing | Requirements for aseptic manufacturing were raised at a time when there was no suitable sterilization method for heat-sensitive pharmaceutical products... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3171 | Cell and Gene Therapy Innovations to Drive Down Costs, Increase Efficiency | Cell and gene therapy is lifesaving for specific and formerly untreatable medical conditions. Very high costs are associated with manufacturing... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3170 | The Difference Between Compliance and Quality | Our journey from compliance to quality is rooted in deep traditions, but are those traditions helping us or hurting us?... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3169 | Continuous Manufacturing for Pharmaceutical Solid Dosage Forms | This course is a blended learning opportunity during which participants will engage in self-paced modules and live virtual education to... | [Link] | Blended eLearning Registration Required | Global | Varies |
| 3168 | Good Manufacturing Practices in the Quality Control Laboratory | This introduction course provides a groundwork for further exploration and application of GMP principles in the quality control laboratory setting.... | [Link] | eLearning Registration Required | Global | Varies |
| 3167 | Pharmaceutical Quality Management Systems: Elements and Quality Review Practice | This course provides an introduction to a Quality Management Systems (QMS) and Pharmaceutical Quality Systems (PQS) in the pharmaceutical industry,... | [Link] | eLearning Registration Required | Global | Varies |
| 3166 | Foundations of GMP | Pharmaceutical manufacturers must comply with the regulatory requirements of the countries where they produce and sell medical products. This free,... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3165 | Foundations of GMP: Water Systems | This eLearning course aims to improve your knowledge and understanding of Good Manufacturing Practice (GMP) requirements of water for usage... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3164 | Foundations of GMP: Heating, Ventilation, and Air Conditioning (HVAC) Systems | This eLearning course aims to improve your knowledge and understanding of Good Manufacturing Practice (GMP) requirements of heating, ventilation, and... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3163 | Foundations of GMP: Auditing | This eLearning course aims to improve your knowledge and understanding of performing Good Manufacturing Practice (GMP) compliance audit. Subject area:... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3162 | Foundations of GMP: Data Integrity and Computer System Validation | This eLearning course aims to improve your knowledge and understanding of Good Manufacturing Practice (GMP) requirements of computer system validation... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3161 | Foundations of GMP: Qualification | This eLearning course aims to improve your knowledge and understanding of Good Manufacturing Practice (GMP) requirements for facility, equipment and... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3160 | Foundations of GMP: Validation | This eLearning course aims to improve your knowledge and understanding of Good Manufacturing Practice (GMP) requirements for validation life cycle,... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3159 | Foundations of GMP: Deviations, Root Cause Analysis (RCA) Tools and Corrective and Preventive Action (CAPA) - Sequence flow for handling of any non-conformance in the GMP environment | This eLearning course aims to improve your knowledge and understanding of Good Manufacturing Practice (GMP) requirements for handling deviations, using... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3158 | Foundations of GMP: Quality Risk Management | This eLearning course aims to improve your knowledge and understanding of Good Manufacturing Practice (GMP) requirements for Quality Risk Management... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3157 | Foundations of GMP: Active Pharmaceutical Ingredient (API) | This eLearning course aims to improve your knowledge and understanding of Good Manufacturing Practice (GMP) requirements for Active Pharmaceutical Ingredient... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3156 | Foundations of GMP: Final Dosage Form | This eLearning course aims to improve your knowledge and understanding of Good Manufacturing Practice (GMP) requirements for Pharmaceutical manufacturers. Subject... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3155 | Data Assurance Throughout Product Lifecycle (CXO) | This course provides an overview of regulatory expectations for data integrity including USFDA, WHO and PIC/s as well as relevant... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3154 | The Challenge of Ensuring Food Quality in a Growing Complex Food Supply Chain | This video discusses the growing complexity of the food ingredient supply chain and introduces USP and its role in food... | [Link] | On-Demand Registration Required | Global | Varies |
| 3153 | Impact of Lipids on the Design and Quality of Liposomal Drug Products | The liposomal “commercial” lipid pool has little variation, and “fancy” lipids (e.g., potentially useful for gene and DNA/RNA delivery, immunological... | [Link] | On-Demand Registration Required | Global | Varies |
| 3152 | The Role and Influence of Excipients in Orally Inhaled Drug Products | Orally inhaled products contain formulation excipients, the effects of which on quality, performance, safety and efficacy must be considered. Only... | [Link] | On-Demand Registration Required | Global | Varies |
| 3151 | Impact of Excipients on Inhalation Drug Products | Differing levels of excipients within inhalation products may have a significant impact on product performance and, from a scientific and... | [Link] | On-Demand Registration Required | Global | Varies |
| 3150 | Why Do We Call Excipients in Topical Products “Inactive Ingredients”? | This presentation discussed the complex functionality of “inactive” ingredients in topical semisolid drug products, and elucidated how topical excipients exert... | [Link] | On-Demand Registration Required | Global | Varies |
| 3149 | Safety Assessments for Excipients in Generic Drugs: A Regulatory Perspective | Excipients in generic drug products are evaluated from clinical and nonclinical perspectives to ensure that they do not alter the... | [Link] | On-Demand Registration Required | Global | Varies |
| 3148 | Improved Excipient Characterization Beyond USP Monographs | This presentation focused on understanding USP–NF excipient monographs and the structural/functional properties of excipients, including the role of each in... | [Link] | On-Demand Registration Required | Global | Varies |
| 3147 | Understanding the Impact of Material Attributes on Product Quality for Continuous Manufacturing | For continuous manufacturing processes, the impact of variation in material attributes on material feeding and process dynamics should be characterized... | [Link] | On-Demand Registration Required | Global | Varies |
| 3146 | Introduction to Pharmaceutical Excipients | Excipients are a very diverse group of materials. They are not active pharmaceutical ingredients (APIs), pharmaceutical finished products or simply... | [Link] | On-Demand Registration Required | Global | Varies |
| 3145 | Opening Remarks, Goals and Anticipated Outcomes | The goals of the workshop included the following: Advance the science of excipient selection and regulatory evaluation. Emphasize that regulatory... | [Link] | On-Demand Registration Required | Global | Varies |
| 3144 | USP SEPC: Evolving Iterative Approaches for Excipients GCs (312 to 316) and LG Polymers | This session will examine the development of General Chapters to as modern analytical tools for use with individual monographs. The... | [Link] | On-Demand Registration Required | Global | Varies |
| 3143 | Atypical Actives – Industry Perspective | Priscilla Zawislak, Chair, IPEC-Americas This presentation from the USP Excipient Stakeholder Forum covers the industry’s perspective on atypical actives, including... | [Link] | On-Demand Registration Required | Global | Varies |
| 3142 | An FDA Perspective on FDA Atypical Active Ingredients | Steven Wolfgang, Ph.D. Center for Drug Evaluation and Research Office of Compliance Office of Drug Security, Integrity and Response This... | [Link] | On-Demand Registration Required | Global | Varies |
| 3141 | USP Perspective on Atypical Actives | Catherine Sheehan, Sr. Director, Science – Excipients, USP This presentation from the USP Excipient Stakeholder Forum covers USP quality standards... | [Link] | On-Demand Registration Required | Global | Varies |
| 3140 | Overview of USP-NF GMP General Chapters Relevant to Excipients | This course will explore the nature of excipients and how they differ from active pharmaceutical ingredients and pharmaceutical finished products.... | [Link] | Blended On-Demand Registration Required | Global | Varies |
| 3139 | Overview of the USP-NF (Complimentary) | This webinar provides an overview of the USP–NF online resource and compendial standards. Attendees will learn about USP Reference Standards... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3138 | What You Always Wanted to Know About USP Reference Standards | This course will provide basic information on USP Reference Standards as highly characterized chemical specimens required for use in USP–NF... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3137 | Introduction to USP Reference Standards | This course will provide information on USP Reference Standards as highly characterized chemical specimens required for use in USP–NF compendial... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3136 | Dietary Supplement-Verification Program Overview | This 60-minute live webinar will inform existing participants, as well as potential customers, about USP and the Dietary Supplement Verification... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3135 | 2024 USP/US FDA Dietary Supplements Workshop | This recorded video brings together experts from US FDA and USP on dietary supplement regulations (DSHEA and 21CFR111), US cGMP... | [Link] | On-Demand Registration Required | Global | Varies |
| 3134 | Overview of Dietary Supplements Regulations in the United States | This one-hour webinar provides an overview of dietary supplements regulations past, present and future. It will cover the evolution of... | [Link] | eLearning Live Webcast On-Demand Registration Required | Global | Varies |
| 3133 | Complimentary Webinar on Nomenclature Guidelines for Dietary Supplements | This webinar explains in detail, with examples, how monograph titles for botanical and non-botanical dietary supplements will be formulated in... | [Link] | On-Demand Registration Required | Global | Varies |
| 3132 | Product Quality Verification of Dietary Supplements | Patients have thousands of dietary supplement options available to them in today's market. Many of these patients will ask you,... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3131 | Current Good Manufacturing Practices (cGMPs) for Dietary Supplements, 21 CFR Part 111 | Expand your knowledge of key elements of cGMPs per 21 CFR Part 111: personnel, physical plants, equipment, production/process control system,... | [Link] | On-Demand Registration Required | Global | Varies |
| 3130 | Botanical ID Methodology Tests | This course offers an overview of the botanical identification methodologies codified in the USP General Chapters Identification of Articles of... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3129 | USP General Chapter 2251 Adulteration of Dietary Supplements with Drugs and Drug Analog | This webinar will expand the audience’s understanding of the scope and magnitude of adulteration of dietary supplements, provide methodological insight,... | [Link] | On-Demand Registration Required | Global | Varies |
| 3128 | Cannabis Quality for Clinical Investigations – Proposed General Chapter | This webinar will describe the validated analytical methods for testing cannabinoid and terpene content, and the relevant USP General Chapters... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3127 | The Either-Or Trap: Consequences of Enhanced Mechanical Calibration vs. Fully Qualifying Dissolution Equipment | This webinar will review how dissolution and drug release testing are used to demonstrate the consistency of pharmaceutical product performance... | [Link] | On-Demand Registration Required | Global | Varies |
| 3123 | USP Medicine Supply Map Workflow Animation Video | The USP Medicine Supply Map (MSM) Animation Video provides users with an overview of the supply chain intelligence tool and... | [Link] | On-Demand Registration Required | Global | Varies |
| 3120 | Introduction to the USP Remdesivir Toolkit | As part of USP’s response to the COVID-19 crisis, a Remdesivir Toolkit containing analytical procedures (e.g., IR, UPLC, NMR, LC-MS)... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3119 | Quality Attributes of Drug Products Applied to the Skin | This webinar will discuss the main critical quality attributes that should be monitored and controlled during product development and/or for... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3118 | Dissolution Apparatus Qualification: USP Guideline on Procedures for Mechanical Qualification and Performance Verification Test: Apparatus 1 and Apparatus 2 | The purpose of these videos is to provide a detailed description of the best practices associated with the Mechanical Qualification... | [Link] | On-Demand Registration Required | Global | Varies |
| 3117 | Pharmaceutical Stability | Learn about essential components for designing global stability programs for pharmaceutical products: regulations, operations, testing, and investigations. Topics include cGMP,... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3116 | USP Bridging Study on DPVS-Prednisone Reference Standard | This webinar will cover specifications for Dissolution Performance Verification Standard – Prednisone Reference Standards (DPVS-Prednisone RS) that were developed and... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3115 | USP Certificate of Lab Procedures | The USP Certificate of Lab Procedures gives prospects a comprehensive understanding of the USP Standards that are applicable and essential... | [Link] | On-demand Certificate Registration Required | Global | Varies |
| 3114 | USP Certificate on Impurities | The USP Certificate on Impurities provides prospects with a comprehensive understanding on USP’s risk-based approach to impurity standards and their... | [Link] | On-demand Certificate Registration Required | Global | Varies |
| 3113 | USP Certificate of Pharmacopeial Analysis | The USP Certificate of Pharmacopeial Analysis provides prospects with the knowledge necessary for analytical validation, verification and transfer and the... | [Link] | On-demand Certificate Registration Required | Global | Varies |
| 3112 | USP Certificate of Document and Reference Standards | The USP Certificate of Document and Reference Standards provides prospect with the knowledge of the effective use of USP standards... | [Link] | On-demand Certificate Registration Required | Global | Varies |
| 3110 | Uniformity of Dosage Units: USP–NF General Chapter | USP General Chapter Uniformity of Dosage Units is internationally harmonized and has been official since USP 34–NF 29 (2011). A... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3109 | Test for Asbestos in USP Talc Chapters and | This course will address the implementation of updated tests for asbestos in the USP Talc monograph and associated chapters and... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3108 | Spectroscopy: General Chapters and Technique-Specific Applications | This course will provide essential training and tools to assist the generation of spectroscopic measurement data that is ‘fit for... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3107 | Bacterial Endotoxin Testing (Lecture Only) | This course provides an understanding of the significance of endotoxin testing in ensuring product safety and compliance with regulatory standards.... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3106 | Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging | The Radiopharmaceuticals – Preparation, Compounding, Dispensing and Repackaging course will expand upon the uniform minimum standards for the preparation, compounding,... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3105 | All the Particulars on Particles: Silicone Oil Droplets | This webinar series will update you on the latest USP developments in Particulate Matter. Silicone oil is present as a... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3104 | All the Particulars on Particles: Gray Zone Particles | This webinar series will update you on the latest USP developments in Particulate Matter. This webinar will focus on gray... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3103 | All the Particulars on Particles: Visible Particles - USP General Chapters , , and | This webinar series will update you on the latest USP developments in Particulate Matters. This webinar will focus on USP... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3102 | All the Particulars on Particles Subvisible Particles—USP General Chapters 787, 788, 1787, and 1788 | This webinar series will update you on the latest USP developments in Particulate Matter. This webinar will focus on USP... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3101 | All the Particulars on Particles: Introduction to Compendial Particulate Standards | This webinar series will keep you informed of the latest USP developments on Particulate Matters. For this introductory session, we... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3100 | Determining Particulate Matter in Liquids: Parenteral & Ophthalmic Products | This course will focus on the current USP General Chapters Particulate Matter in Injections and Methods for the Determination of... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3099 | All the Particulars on Particulates - Ophthalmic Products | This webinar series will update you on the latest USP developments in Particulate Matter. This webinar will focus on USP... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3098 | NMR General Chapters and Best Practices for Compliance | This course covers General Chapters and , highlighting key advancements in Nuclear Magnetic Resonance Spectroscopy (NMR) and quantitative NMR (qNMR)... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3097 | Dissolution/Drug Release tests of Drug Products Applied to the Skin | This webinar will discuss USP General Chapters and and will present the equipment, most common conditions, and challenges for the... | [Link] | On-Demand Registration Required | Global | Varies |
| 3096 | Fundamentals of Dissolution: Guidance for the Verification and Qualification of a Dissolution Apparatus | This course will emphasize the fundamentals of dissolution testing of solid oral dosage forms and address specifics related to the... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3095 | Use of Enzymes in the Dissolution Testing of Gelatin Capsules | This webinar discusses the procedure to be used in the dissolution testing of gelatin capsules when they fail the two-tier... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3094 | Introduction to Rapid Microbiological Methods (RMMs) | This course provides an in-depth understanding of microbiological practices in the pharmaceutical industry, emphasizing the latest advancements in rapid microbiological... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3093 | Water Conductivity: USP General Chapter | USP General Chapter Water Conductivity is the primary method for determining inorganic/ionic impurities in Purified Water and Water for Injection... | [Link] | On-Demand Registration Required | Global | Varies |
| 3092 | Total Organic Carbon: USP General Chapter | USP General Chapter Total Organic Carbon (TOC) is official and it has been adopted by other pharmacopoeias as the primary... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3091 | Compendial HPLC Practices | This course covers USP General Chapter Chromatography, with focus on system suitability parameters and adjustments allowed to the chromatographic system.... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3089 | Inhalation and Nasal Products | This course focuses on the major aspects related to the quality and performance of aerosols and inhaled medications as described... | [Link] | Blended Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3088 | Microbiology and Sterility Assurance | This course offers participants a comprehensive insight into USP requirements for microbiology and sterility assurance. Additionally, it provides guidelines for... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3087 | User-Determined Reporting Thresholds | Measurement tools and models give a deeper understanding of process behaviors like viewing your process in a higher resolution. During... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3086 | Impurities in Drug Products and Drug Substances - A USP Approach | This course integrates ICH Guidance and FDA policy for impurities, relevant USP General Chapters about impurities, and USP’s approach to... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3085 | USP General Chapters Residual Solvents and Residual Solvents-Verification of Compendial Procedures | This course focuses on the control of residual solvents in pharmaceutical products to ensure patient safety. It is primarily based... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3084 | Understanding USP Requirements for Balances | This course discusses in detail, with examples, the USP requirements on balances and USP perspectives of Weighing on an Analytical... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3082 | Good Pharmaceutical Packaging: Extractables and Leachables (1-day) | The course will address the increased regulatory concerns regarding extractables and leachables related to the interaction of drug products with... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3081 | Good Pharmaceutical Packaging: Extractables and Leachables (1-1/2 day) | This course focuses on extractables and leachable(E&L) as it relates to the interaction between drug products and their various contact... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3080 | USP Nitrosamines Impurities On- Demand Video Tutorials | Nitrosamines are a critical topic for regulators and industry given the recent safety recalls of several products containing these impurities.... | [Link] | On-Demand Registration Required | Global | Varies |
| 3079 | USP Nitrosamines Impurities | Nitrosamines are a critical topic for regulators and industry given the recent safety recalls of several products containing this impurity.... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3078 | Pharmaceutical Waters | This two-day course explains compendial and regulatory requirements for source waters, purified water, water for injection(s), sterile water for injection... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3077 | USP–NF General Chapter – Microbial Control of Pharmaceutical Water Systems | Much of USP–NF General Chapter Water for Pharmaceutical Purposes is devoted to instructing the water system owner/user of the issues... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3076 | Validation of Pharmaceutical Water System: USP General Chapter | Pharmaceutical water systems must be appropriately designed, operated, and maintained in order to produce high quality water. USP General Chapter... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3075 | Microbiological Analysis of Pharmaceutical Water: USP General Chapter | Pharmaceutical Water Systems must be appropriately maintained in order to produce high quality water. USP General Chapter Water for Pharmaceutical... | [Link] | On-Demand Registration Required | Global | Varies |
| 3074 | Sterilization and Sterility Assurance | This course will offer participants a comprehensive insight into USP requirements for microbiology and sterility assurance in the context of... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3073 | Validation, Verification and Transfer of Analytical Procedures | Learn about parameters for validating analytical procedures for small molecules based on USP−NF General Chapters Validation of Compendial Procedures and... | [Link] | Classroom On-Demand Registration Required | Global | Varies |
| 3072 | Validation and Verification of USP Microbiological Methods | This course provides detailed parameters on validation and verification of microbiological tests, recovery from pharmacopeial articles, and validation criteria for... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3070 | Analytical Procedure Life Cycle and Application of the AQbD Approach | Based on USP General Chapter , this course provides an understanding of how to apply the Analytical Procedure Life Cycle... | [Link] | Blended Classroom eLearning Live Webcast Registration Required | Global | Varies |
| 3069 | USP General Chapter Statistical Tools for Procedure Validation | This course introduces key components of USP–NF General Chapter Statistical Tools for Procedure Validation. This chapter provides statistical concepts used... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3068 | Container Closure Integrity: Methods & Application | This course discusses the USP Package Integrity Evaluation series of general chapters. This course will focus on the practical aspects... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3067 | Overview of USP Microbiology Chapters | This course establishes an understanding of microbiological best practices, classical (culture-based) and alternative, their advantages and disadvantages and their validation... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3066 | Development and Validation of Dissolution Procedures | This course discusses the recommendations for dissolution method development and validation stated in the USP General Chapter . Building on... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3065 | Impurities and Forced Degradation Studies | This course will cover the main aspects related to the control of impurities in drugs and medicines and the application... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3064 | Risks and Mitigation Strategies on the Storage and Transport of Finished Drug Products | This course will cover the main aspects USP General Chapter Supply Chain Risks and Mitigation Strategies on the Storage and... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3063 | Enhancement of General Chapter Analytical Instruments and Systems Qualification; a full lifecycle approach | United States Pharmacopoeia (USP) has two General Chapters summarizing the lifecycle approaches and requirements to ensure data quality by demonstrating... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3062 | Process Analytical Technology Theory and Practice | USP General Chapter Process Analytical Technology – Theory and Practice has been published in USP’s Pharmacopeial Forum for public comments.... | [Link] | On-Demand Registration Required | Global | Varies |
| 3061 | Good Documentation Practices (GDP) and Record Keeping Best Practices | . Good Documentation Practices (GDP) is an essential element in regulated manufacturing and laboratory environments. Personnel working in these fields... | [Link] | eLearning Registration Required Self-paced | Global | Varies |
| 3060 | Good Documentation Practices (GDP) and USP–NF General Chapter | Good Documentation Practices (GDP) is essential in regulated manufacturing and laboratory environments. Personnel in these fields need to closely adhere... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3059 | USP Analytical Data – Interpretation and Treatment | This course expands on the key elements of USP–NF General Chapter concerning acceptable statistical concepts and practices for the analysis... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 3057 | USP Standards to Support Quality of COVID-19 Vaccines for the Global Community | As researchers and manufacturers develop and produce vaccines to protect against COVID-19 and other infectious agents, it is critical to... | [Link] | On-Demand Registration Required | Global | Varies |
| 3056 | COVID 19 Vaccine Distribution and Storage: Increasing Access to Quality, Safe, and Effective Vaccine Products | In June 2021, the leaders from the Group of Seven industrialized nations committed to sharing at least 1 billion COVID-19... | [Link] | On-Demand Registration Required | Global | Varies |
| 3055 | Analysis of Charge Variants in Biologics | This course explains why measurement of charge variants is important. It will also describe multiple techniques (i.e., ion exchange chromatography,... | [Link] | On-Demand Registration Required | Global | Varies |
| 3054 | mRNA Open Forum: Collaborating to pave the way for mRNA-based vaccines and therapeutics quality | The rapid design and development of mRNA-based vaccines for the COVID-19 pandemic brought mRNA technology to the forefront of medical... | [Link] | On-Demand Registration Required | Global | Varies |
| 3053 | mRNA Vaccines Series: CMC and Analytics | The development and approval of mRNA-based vaccines for COVID-19 revealed the potential of this platform for both preventative and therapeutic... | [Link] | On-Demand Registration Required | Global | Varies |
| 3052 | mRNA Vaccines Series: Principles and Production | This webinar will cover general principles and modes of action for mRNA vaccines. It will also cover the production process... | [Link] | On-Demand Registration Required | Global | Varies |
| 3051 | USP Raw Material Standards to Support Quality of Pegylated Therapeutics | This course will introduce the use of polyethylene glycol (PEG) as a raw material used for conjugation with biologic molecules.... | [Link] | On-Demand Registration Required | Global | Varies |
| 3050 | Opportunities and Challenges in Raw Material and Starting Material Qualification for Cell and Gene Therapy Products | Understanding and controlling raw material variability requires a risk-based approach through the lens of deep technical experience and knowledge. For... | [Link] | On-Demand Registration Required | Global | Varies |
| 3049 | Raw Materials Quality: Requirements, Limitations, and Recommendations (from an Ancillary Material Manufacturer’s Perspective) | As Ancillary Materials (AM) supplier of cytokines and media we are reflecting on current requirements for AM quality systems and... | [Link] | On-Demand Registration Required | Global | Varies |
| 3048 | Strategy to Determine Impact of Complex Raw Material Variability on Process Performance | Raw materials, in particular cell culture media, represent a significant source of variability to biopharmaceutical manufacturing processes that can detrimentally... | [Link] | On-Demand Registration Required | Global | Varies |
| 3047 | Practical Considerations for Gamma Irradiation of Serum | Quality and safety of animal origin components used in the biologics manufacture is of the paramount importance in assuring quality... | [Link] | On-Demand Registration Required | Global | Varies |
| 3046 | Impact of Elemental Impurities in Biologics development and Manufacturing & Risk Management for Control Measures | Trace elements have significant biological relevance and can impact key performance and quality attributes of biological processes. This presentation will... | [Link] | On-Demand Registration Required | Global | Varies |
| 3045 | A Combination of Strategic Planning and Technical Assessment to Overcome Raw Material Management Challenges | In Biologics Therapeutics Manufacturing, an appropriate raw material management strategy in a systematic manner is a key factor to ensure... | [Link] | On-Demand Registration Required | Global | Varies |
| 3044 | An Attribute Focused Approach to Identify and Control Raw Material Variability | Raw materials are a fundamental element in the manufacturing of biopharmaceuticals that can impact the performance of the manufacturing process... | [Link] | On-Demand Registration Required | Global | Varies |
| 3043 | Viral Safety of Raw Materials Used in Production of ATMPs | Fetal Bovine Serum is commonly used at cell culture supplement for production of vaccines and viral gene transfer vectors. However,... | [Link] | On-Demand Registration Required | Global | Varies |
| 3042 | Advanced Raw Material Control: Rapid ID and Raw Material Informatics | Advanced raw material control appropriately identifies risk, deploys limited resources to manage this risk, and increases upstream supply chain flexibility... | [Link] | On-Demand Registration Required | Global | Varies |
| 3041 | Applying Online Analytical Tools to Characterize Cell Culture Medium Preparation | Variability in cell culture media can directly affect the biotherapeutic manufacturing process performance and drug substance quality. This variability is... | [Link] | On-Demand Registration Required | Global | Varies |
| 3040 | Analytical Aspects of Control and Characterization: Polysorbate Case Study | Polysorbates (mainly PS20 and PS80) are critical excipients in (bio-)pharmaceutical formulations that protect the contained therapeutic proteins from interfacial stress.... | [Link] | On-Demand Registration Required | Global | Varies |
| 3039 | New Understanding Relating to Existing Excipients and Formulation Approaches | As part of USPs work to strengthen the Polysorbate monographs, the USP Excipients Expert Committee is evaluating technologies and methods... | [Link] | On-Demand Registration Required | Global | Varies |
| 3038 | Quality Considerations for Critical Materials in Gene-Based Therapies | A number of gene-based cell therapies are in development with several products already in commercial phase. Human primary cells and... | [Link] | On-Demand Registration Required | Global | Varies |
| 3037 | Raw Material Controls for Biologics: Inspectional Experience | Control of materials is critical to ensure manufacturing consistency, resulting safety, quality and effectiveness of a product, and ultimately its... | [Link] | On-Demand Registration Required | Global | Varies |
| 3036 | Regulatory Considerations for Raw Material Qualification and Related Controls for Biotechnology Drugs | This course covers: *Background on raw materials as a critical component of good manufacturing practices *Types of raw materials -... | [Link] | On-Demand Registration Required | Global | Varies |
| 3035 | Qualification of Raw Materials Used in the Manufacturing of Cellular Therapies | Qualification of raw materials used in the manufacturing of cellular therapies requires the use of risk assessment strategies to categorize... | [Link] | On-Demand Registration Required | Global | Varies |
| 3034 | Biosimilars: Meeting the FDA with Your Biosimilar Product | In the rapidly evolving biosimilar landscape, regulatory approval remains a critical challenge for manufacturers seeking to bring these complex products... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3033 | Modern Approaches to mRNA Manufacturing | mRNA market in 2021 grew exponentially due to the success of COVID-19 vaccines by BioNTech, Johnson and Johnson and Moderna.... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3032 | Cost Savings Related to Qualifying Cell & Gene Therapy Facilities | Viral vector and cell/gene therapy facilities can be less complicated and require fewer critical utilities when compared to pharmaceutical or... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 3031 | Immunogenicity Risk Assessment of Peptide Drugs and their Impurities | The US generic peptide drug market is valued at $62 billion USD in 2023 and is expected to increase in... | [Link] | On-Demand Registration Required | Global | Varies |
| 3030 | Process improvements to effect more efficient and greener peptide synthesis | For synthesis of peptides, conventional approach utilizes linear solid phase peptide synthesis (SPPS) that is known to produce Des impurities,... | [Link] | On-Demand Registration Required | Global | Varies |
| 3029 | LC-HRMS-based Multi-attribute Method for Oligonucleotides (MAMO): Characterization and Impurity Profiling | A significant challenge in the development, manufacturing, and regulatory evaluation of both new and generic synthetic oligonucleotide drugs is the... | [Link] | On-Demand Registration Required | Global | Varies |
| 3028 | Improving TIDES product risk assurance with NMR spectroscopy | The wealth of structural information that accompanies NMR spectroscopy has made it instrumental for traditional small molecules medicinal and analytical... | [Link] | On-Demand Registration Required | Global | Varies |
| 3027 | Synthetic Oligonucleotide Impurity Analysis: Enhancing the Conventional Single Quad Method Using UPLC-ToF-MS | As synthetic oligonucleotide therapeutics gain increasing interest for drug products, having efficient methods for determining their impurity profiles is critical,... | [Link] | On-Demand Registration Required | Global | Varies |
| 3026 | Analytical toolbox to enable the synthesis and release of complex synthetic peptides | Peptides are gaining tremendous importance as modern drug substances. Addressing the urge for chemically complex high-quality drugs, cutting edge approaches... | [Link] | On-Demand Registration Required | Global | Varies |
| 3025 | Holistic control strategy of oligonucleotides starting materials | In the synthesis of oligonucleotides, the control strategy of starting materials is essential to guarantee manufacturing process reliability and API... | [Link] | On-Demand Registration Required | Global | Varies |
| 3024 | Framework for Evaluating Impurity Risks in Starting Materials for Oligonucleotide API Manufacturing | In the oligonucleotide therapeutics industry, the purity of active pharmaceutical ingredients (API) is paramount. Impurities in starting materials (SM) can... | [Link] | On-Demand Registration Required | Global | Varies |
| 3023 | CMC Regulatory Experiences and Expectations for Peptides | The diversity and complexity of peptide therapeutics pose challenges for the characterization and impurity control of such medicines. This presentation... | [Link] | On-Demand Registration Required | Global | Varies |
| 3022 | CMC Challenges in FDA-approved Synthetic Oligonucleotide Drugs | Oligonucleotide drugs are a special class of therapeutics that are not explicitly covered by the regulatory and CMC guidance which... | [Link] | On-Demand Registration Required | Global | Varies |
| 3021 | USP Standards to Support Quality of Peptide and Oligonucleotide Therapeutics | This webinar provides an overview of USP documentary and physical reference standards to support therapeutic peptides. It introduces USP existing... | [Link] | On-Demand Registration Required | Global | Varies |
| 3020 | Novel Approaches for Mass Spectrometry Characterization of Highly Modified Synthetic RNA | Over the last years, the demand of MS based structural characterization approaches in quality control of oligonucleotide based pharmaceuticals increased... | [Link] | On-Demand Registration Required | Global | Varies |
| 3019 | Developing Product-specific Guidances on Oligonucleotides for Generic Drug Development | Synthetic oligonucleotides are short nucleic acid chains produced by chemical synthesis that can control gene expression in a sequence specific... | [Link] | On-Demand Registration Required | Global | Varies |
| 3018 | Characterization of Low-level D-Amino Acid Degradation Impurities Using Liquid Chromatography-High Resolution Tandom Mass Spectrometry | Introduction. Trace amount of impurity may influence the efficacy and safety of the pharmaceuticals, which requires comprehensive analysis of the... | [Link] | On-Demand Registration Required | Global | Varies |
| 3017 | In-depth Impurity Profiling of Synthetic Oligonucleotides by High Resolution Mass Spectrometry | One of the primary challenges in synthetic oligonucleotide drug development and application review is the imprecision of commonly used analytical... | [Link] | On-Demand Registration Required | Global | Varies |
| 3016 | Risk Assessment for a Nitrosamine Contamination of Peptide APIs Manufactured by Solid-Phase Peptide Synthesis (SPPS) | Due to findings of nitrosamines in multiple medicines since July 2018, both the FDA and the EMA published guiding documents... | [Link] | On-Demand Registration Required | Global | Varies |
| 3015 | Current CMC Regulatory Experiences and Expectations for Oligonucleotides | This presentation will provide an overview about the regulatory landscape for oligonucleotides. Issues related to the pharmaceutical quality of oligonucleotides... | [Link] | On-Demand Registration Required | Global | Varies |
| 3014 | Quantitation of Impurities in Tirzepatide Peptide Fragments by High Resolution Ultra-High Pressure Liquid Chromatography-Mass Spectrometry (UHPLC-MS) | Tirzepatide is a novel 39 amino acid residue GIP (gastric inhibitory polypeptide) and GLP-1 (glucagon-like peptide-1) dual receptor agonist targeted... | [Link] | On-Demand Registration Required | Global | Varies |
| 3013 | Analytical Strategies for Characterization of Stereopure Platform Chemistry | Traditional phosphorothioate oligonucleotide synthesis methods generate stereoisomeric mixtures composed of thousands of PS-modified molecules. Wave Life Sciences is pioneering the... | [Link] | On-Demand Registration Required | Global | Varies |
| 3012 | Analytical Method Development for Critical Impurities in Phosphoramidites | An overview of various analytical approaches for the detection, identification, and control of critical impurities in phosphoramidites will be presented... | [Link] | On-Demand Registration Required | Global | Varies |
| 3011 | Fmoc Alpha Methyl Quaternary Amino Acid Supply Chain Development | The implementation of Non-Coded amino acids to improve stability and function in therapeutic peptides is an active area of research.... | [Link] | On-Demand Registration Required | Global | Varies |
| 3010 | Strategies for the Control of Impurities in Oligonucleotide Synthesis | Solid-phase synthesis is predominantly used today for the manufacture of oligonucleotide therapeutics. Impurities in the oligonucleotide API need to be... | [Link] | On-Demand Registration Required | Global | Varies |
| 3009 | Evaluation of Chromatographic Techniques for Oligonucleotide Separation and Subsequent Detection by HRMS for Routine Testing | Standard approaches to LC separation of oligonucleotides include an ion pair, an acid modifier and a C18 column. Attempts have... | [Link] | On-Demand Registration Required | Global | Varies |
| 3008 | CMC Regulatory Considerations for Oligonucleotides and Peptides: Similarities and Differences | This presentation will provide an overview what can oligonucleotide and peptide developers learn from each other in their regulatory experiences,... | [Link] | On-Demand Registration Required | Global | Varies |
| 3007 | Applications of Green Chemistry in Oligonucleotide Manufacturing | Processes that provide economical, safe, and green access to chemically modified oligonucleotides is of paramount importance in the manufacturing of... | [Link] | On-Demand Registration Required | Global | Varies |
| 3006 | Application of NMR Spectroscopy for Characterization and Identity Testing of Oligonucleotide Drug Molecules | With recent introduction of several new Oligonucleotide based drugs to the market, an increased need for high quality analytics to... | [Link] | On-Demand Registration Required | Global | Varies |
| 3005 | Method Development for the Characterization of Synthetic Oligonucleotides by LC-MS | The primary method for quantitation and characterization of synthetic oligonucleotides is ion-pair reversed phase liquid chromatography (IP-RPLC). Mobile phase composition... | [Link] | On-Demand Registration Required | Global | Varies |
| 3004 | Drug Delivery Systems and Life Cycle Management for Peptides Beyond the Vial and Syringe | There are an abundant number of examples of commercial peptides in lyophilized powder or aqueous solution format and some peptides... | [Link] | On-Demand Registration Required | Global | Varies |
| 3003 | CMC and Regulatory Challenges for Oligonucleotide Drugs | Oligonucleotide drugs are a special class of therapeutics that are not explicitly cover by the regulatory and CMC guidances that... | [Link] | On-Demand Registration Required | Global | Varies |
| 3002 | Vendor Selection for Unusual Amino Acid Derivatives | Starting material quality is critical for the final API quality. For the synthesis of therapeutic peptides, the normal proteinogenic Fmoc... | [Link] | On-Demand Registration Required | Global | Varies |
| 3001 | Considerations of Comparative Studies for Complex Synthetic Peptide Products | During the development of complex generic peptide products, the amount of comparative studies required by the FDA have been on... | [Link] | On-Demand Registration Required | Global | Varies |
| 3000 | Antisense Oligonucleotide Specification and Release Tests using a Risk-Based Platform Approach | The establishment of appropriate specifications and release tests for drug substance and product is a crucial part of an analytical... | [Link] | On-Demand Registration Required | Global | Varies |
| 2999 | Synthesis of Tirzepatide by Native Chemical Ligation (NCL), a Once-weekly dual GIP and GLP-1 Receptor Agonist | Tirzepatide, a 39-amino acid synthetic peptide, is a once-weekly novel dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like-peptide-1) receptor agonist.... | [Link] | On-Demand Registration Required | Global | Varies |
| 2998 | Regulatory Considerations for Setting Smart Starting Material Specifications | Starting material specifications are a key element of the overall control strategy for synthetic oligonucleotides. In this presentation, we share... | [Link] | On-Demand Registration Required | Global | Varies |
| 2997 | Terminal Sterilisation of Oligonucleotide Drug Products | Terminal sterilisation is the process whereby a product is sterilised in its final container. This sterilisation process has always been... | [Link] | On-Demand Registration Required | Global | Varies |
| 2995 | Quality considerations for plasmid DNA as a starting material for cell and gene therapies | There is a need for more guidance regarding plasmid DNA used in the manufacturing of cell and gene therapy processes,... | [Link] | On-Demand Registration Required | Global | Varies |
| 2994 | Characterization and Biological Relevance of Protein Aggregates and Other Particles 100 20,000 nm in Size (Sub Micron and Subvisible) | Analysis of subvisible and visible particles—including foreign particles, protein aggregates from the API in biologics, microbubbles, and silicon oil droplets—is... | [Link] | On-Demand Registration Required | Global | Varies |
| 2993 | What’s New in Biologics? Analysis of Heparin Sodium Porcine and Bovine | Heparin sodium is an important anticoagulant with many indications, use in blood transfusions and dialysis procedures and the treatment of... | [Link] | On-Demand Registration Required | Global | Varies |
| 2992 | What’s New in Biologics? Potency Assays to Evaluate Coagulation Factor VIII and Factor IX | Hemophilia is a severe disorder caused by insufficient clotting proteins. Deficiencies in two of these proteins, coagulation factors VIII or... | [Link] | On-Demand Registration Required | Global | Varies |
| 2991 | What’s New in Biologics? Standards to Support Advanced Therapies | About 20 years ago, USP began supporting development and quality assessments of cell, gene and tissue-engineered products by producing a... | [Link] | On-Demand Registration Required | Global | Varies |
| 2990 | What’s New in Biologics? Focus on USP’s Vaccine Initiatives | Along with clean water and sanitation, vaccines are one of the most effective tools to support global public health. Since... | [Link] | On-Demand Registration Required | Global | Varies |
| 2989 | What's New in Biologics? Focus on USP’s Monoclonal Antibody Reference Standards | Many therapeutic monoclonal antibodies (mAbs) have been licensed or are in development to treat a wide variety of diseases, including... | [Link] | On-Demand Registration Required | Global | Varies |
| 2986 | Best Practices for Mass Spectrometry-Based Multi-Attribute Method (MAM) for Therapeutic Proteins USP General Chapter 1060 | Multi-Attribute Method (MAM) for analytical testing of biotherapeutics is gaining traction due to its potential to improve efficiency and provide... | [Link] | On-Demand Registration Required | Global | Varies |
| 2985 | Development and Characterization of Monoclonal Antibody Therapeutics | Many therapeutic monoclonal antibodies (mAbs) have been licensed or are in development to treat a wide variety of diseases, including... | [Link] | On-Demand Registration Required | Global | Varies |
| 2984 | Best Practices for Residual Host Cell Protein Measurement in Biopharmaceuticals by Mass Spectrometry: USP Chapter | Protein-based biotherapeutics are produced by numerous prokaryotic and eukaryotic cellular expression systems. During the manufacture of these products, host cell... | [Link] | On-Demand Registration Required | Global | Varies |
| 2983 | Regulatory and WHO Prequalification Considerations for Vaccines | This course will address the process for World Health Organization prequalification of vaccines. Participants will better understand the laboratory information... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 2982 | Quality Control of Vaccines Manufacturing | This course provides best practices for bioanalytical and analytical laboratories that support the quality control of vaccines. The course offers... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 2981 | Production of Vaccines and Sterile Biologics | This twelve-hour course will provide International Council for Harmonization (ICH) and World Health Organization (WHO) guidelines related to vaccine manufacturing... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 2980 | Cell Banking for Manufacturing of Vaccines | This course will provide International Council for Harmonization , World Health Organization, and USP guidelines related to cell banking and... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 2979 | Introduction to GMP Manufacturing and Characterization of Vaccines for Human Use | This course provides a general overview of manufacturing and characterization of vaccines including vaccine types, components, and functions. Fundamental concepts... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 2978 | Viral Vector Manufacturing and Control Strategies | Viral gene transfer vector manufacturing for in vivo and ex vivo applications has largely been in support of early phase... | [Link] | On-Demand Registration Required | Global | Varies |
| 2977 | USP-APEC: Virtual Training Workshop on Chemistry, Manufacturing and Control Challenges in CAR T Cell Therapy | The USP-APEC Center of Excellence for Advanced Therapies Virtual Training will convene regulators from APEC member economies to build regulatory... | [Link] | On-Demand Registration Required | Global | Varies |
| 2976 | Development and Validation of Bioassays for Advanced Therapies Workshop | USP is an Asia-Pacific Economic Cooperation (APEC) Center of Excellence for the Advanced Therapies priority work area. This priority work... | [Link] | On-Demand Registration Required | Global | Varies |
| 2968 | USP Antibiotic Compendial Standards and Modernization Approaches | Ensuring the quality of antibiotics is more important than ever as additional data shows that quality plays a role in... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 2967 | ATCC-USP Joint Webinar: Residual DNA Testing | Residual DNA testing is required for demonstrating clearance of DNA from the cell substrate used to manufacture biologics for therapeutic... | [Link] | On-Demand Registration Required | Global | Varies |
| 2966 | USP Standards that Support the Development and Characterization of Biologics | This webinar describes some of the USP standards published as chapters in the United States Pharmacopeia – National Formulary (USP–NF).... | [Link] | On-Demand Registration Required | Global | Varies |
| 2965 | Residual DNA Testing | Residual DNA testing is required for demonstrating clearance of DNA from the cell substrate used to manufacture biologics for therapeutic... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 2964 | USP Standards to Support the Characterization of mAbs: Applications and General Chapter | USP offers solutions to evaluate the quality attributes of monoclonal antibodies (mAbs) for therapeutic use. The validated methods that are... | [Link] | On-Demand Registration Required | Global | Varies |
| 2963 | Quantifying Host Cell Proteins by LC-MS: Experimental Demonstration and Method Comparison in USP 1132.1 | While no specific limits exist in regulatory guidance for Host Cell Proteins (HCPs), according to ICH Q6B specifications, HCP impurities... | [Link] | On-Demand Registration Required | Global | Varies |
| 2962 | Assays to Evaluate Fragment Crystallizable (Fc)-Mediated Effector Function | Fc effector function activities are mediated via interaction of the fragment antigen binding (Fab) domain of a therapeutic monoclonal antibody... | [Link] | On-Demand Registration Required | Global | Varies |
| 2960 | USP Standards and Best Practices for Gene Therapy | Gene therapies offer tremendous promise to address human disease but their complexity and diversity present unique challenges to those seeking... | [Link] | On-Demand Registration Required | Global | Varies |
| 2959 | Bioassay Design, Development and Validation | This bioassay course will focus on factors to be considered in the design, development and validation of bioassays. The course... | [Link] | Classroom Live Webcast On-Demand Registration Required | Global | Varies |
| 2958 | Evaluation Strategy for Trace Elements in Cell Culture Media Used in the Manufacture of Recombinant Proteins | This webinar will discuss the new USP General Chapter Evaluation Strategy for Trace Elements in Cell Culture Media Used in... | [Link] | Live Webcast On-Demand Registration Required | Global | Varies |
| 1851 | Pharmacovigilance (Level 3) | Purpose: To develop advanced expertise in pharmacovigilance science, risk assessment, and regulatory oversight, enabling experienced evaluators to lead complex safety... | [Link] | Registration Required | Africa, South Africa | Free |
| 1872 | Pharmacovigilance (Level 2) | Purpose: To develop applied competence in the evaluation, analysis, and management of pharmacovigilance data to support regulatory review and post-marketing... | [Link] | Registration Required | Africa, South Africa | Free |
| 1873 | Pharmacovigilance (Level 1) | Purpose: To introduce regulatory staff, healthcare professionals, and industry personnel to the fundamental principles of pharmacovigilance (PV) and the importance... | [Link] | Registration Required | Africa, South Africa | Free |
| 1857 | Good Manufacturing Practice - GMP (Level 1) | Purpose: To introduce regulatory officers, inspectors-in-training, and quality professionals to the fundamental principles and objectives of Good Manufacturing Practice (GMP)... | [Link] | Registration Required | Africa, South Africa | Free |
| 1856 | Good Manufacturing Practice - GMP (Level 2) | Purpose: To develop practical competence in the application of GMP principles through inspection planning, execution, and reporting.This level equips learners... | [Link] | Registration Required | Africa, South Africa | Free |
| 1852 | Good Manufacturing Practice - GMP (Level 3) | Purpose: To develop advanced inspectional, analytical, and regulatory decision-making expertise for senior inspectors and GMP specialists responsible for oversight of... | [Link] | Registration Required | Africa, South Africa | Free |
| 1847 | Clinical Trials (Level 2) | Purpose: To develop intermediate competence in the regulatory evaluation, monitoring, and management of clinical trials, focusing on practical application of... | [Link] | Registration Required | Africa, South Africa | Free |
| 1844 | Clinical Trials (Level 1) | Purpose: To introduce regulatory professionals, investigators, and stakeholders to the fundamental principles and regulatory requirements governing the conduct of clinical... | [Link] | Registration Required | Africa, South Africa | Free |
| 1841 | Clinical Evaluation of regulatory dossiers (Level 3) | Purpose: To develop advanced expertise in clinical data assessment and regulatory decision-making for complex products and innovative therapies.This level equips... | [Link] | Registration Required | Africa, South Africa | Free |
| 1838 | Clinical Evaluation of regulatory dossiers (Level 2 _ Additional) | [Link] | Registration Required | Africa, South Africa | Free | |
| 1835 | Clinical Evaluation of Regulatory Dossiers (Level 1 & 2) | Purpose: To introduce regulatory professionals to the fundamental principles, processes, and ethical considerations underpinning clinical evaluations in medicine regulation.This level... | [Link] | Registration Required | Africa, South Africa | Free |
| 1832 | Biostatistics (Level 2) | Purpose: To build applied competence in the use of biostatistical methods for the design, analysis, and interpretation of data from... | [Link] | Registration Required | Africa, South Africa | Free |
| 1829 | Biostatistics for regulators (Level 1) | Purpose: To introduce regulatory professionals to the fundamental principles of biostatistics and their application in the evaluation of medicines and... | [Link] | Registration Required | Africa, South Africa | Free |
| 1825 | BA-BE (Level 3) | Purpose : To develop advanced analytical and regulatory evaluation skills for in-depth assessment and decision-making in bioavailability and bioequivalence studies,... | [Link] | Registration Required | Africa, South Africa | Free |
| 1812 | Regulation of Biotherapeutics & Vaccines (Level 2) | Purpose: To provide regulatory professionals with a comprehensive foundational understanding of the science, development, and regulatory principles governing biotherapeutics and... | [Link] | Registration Required | Africa, South Africa | Free |
| 1815 | Regulation of Biotherapeutics & Vaccines (Level 3) | Purpose: To equip regulatory scientists and evaluators with advanced technical and regulatory skills required for in-depth assessment and decision-making regarding... | [Link] | Registration Required | Africa, South Africa | Free |
| 1818 | BA-BE (Level 1 and 2) | Purpose: To build foundational and intermediate competence in the principles, design, and regulatory evaluation of bioavailability and bioequivalence studies for... | [Link] | Registration Required | Africa, South Africa | Free |
| 1769 | Excellence in Pharmacovigilance: GVP Modules I to XVI | Organized and delivered in collaboration with the Dutch Medicines Evaluation Board (MEB), this face-to-face interactive training course covers the major... | [Link] | Europe | Paid | |
| 1770 | Quality Management Systems (QMS) in Medical Devices | The Quality Management in Medical Devices Training Course provides comprehensive insights into the internationally recognized standard for quality management systems... | [Link] | Paid | ||
| 1771 | Lead Auditor - Medical devices | This course develops competency in quality management systems auditing for medical devices, aligning with ISO 13485 and global regulatory expectations.... | [Link] | Instructor-led Registration Required | Paid | |
| 1768 | Foundations of Good Manufacturing Practices – USP | Pharmaceutical manufacturers must comply with the regulatory requirements of the countries where they produce and sell medical products. This free,... | [Link] | Certification Available Registration Required Self-paced | Free | |
| 1755 | USP Education Regulatory System Strengthening Catalog | More that 250 self-paced offerings available for free to medicine regulatory authorities and manufacturers in Africa through 2026. To support... | [Link] | Certification Available Registration Required | Global | Free, Paid, Discount for LMICs |
| 1754 | Animal Testing Replacement For Vaccines, A One Health View: Global Outlook And Future Strategy | The Humane World for Animals and IABS have been collaborating together since the 2019 IABS conference “Animal Testing for Vaccines Implementing... | [Link] | Registration Required | Global | Varies, Discount for LMICs |
| 1708 | WHO Academy | Discover a vast collection of high-quality courses on essential health topics. The WHO Academy provides top-tier courses designed by learning... | [Link] | Available in other languages Registration Required Self-paced | Global | Free |
| 1587 | EudraVigilance: Training and Support | EMA’s training hub for EudraVigilance, including EVWEB/electronic reporting, GVP Module VI alignment, and user support. | [Link] | Registration Required | Europe | Varies |
| 1535 | FDA/C-Path Institute Model Informed Drug Development Web-Based Training | The U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) Quantitative Medicine Center of Excellence (QM... | [Link] | Self-paced | Global | Free |
| 1550 | Case series causality assessment | UMC instructor-led online course on assessing causality for a group of ICSRs with the same medicine/event; practical group exercises for... | [Link] | Instructor-led | Global | Free |
| 1551 | Quantitative signal detection using VigiLyze | UMC instructor-led online course on quantitative signal detection with practical exercises using VigiLyze; suited to national PV centres and assessors. | [Link] | Instructor-led | Global | Free |
| 1588 | Clinical Trials Information System (CTIS): Training & Support | EMA’s CTIS training (modules, webinars and DIA sponsor end‑user training) to support compliance with EU CTR. EMA offers live training sessions to provide additional... | [Link] | Instructor-led Self-paced | Europe | Varies |
| 1590 | A Primer for Clinical Assessors within African Regulatory Agencies (Self-Paced) | Welcome to this self-paced / self-study version of “A Primer for Clinical Assessors within African Regulatory Agencies” course! These training... | [Link] | Registration Required Self-paced | Global | Free |
| 1601 | Clinical Data: Safety, Risk Management and Mitigation (Clinical Assessor Course - Self Paced) | This training examines how clinical data underpin safety evaluation, risk management, and mitigation throughout a product’s life cycle. It covers... | [Link] | Registration Required Self-paced | Africa | Free |
| 1600 | Critical Review of Clinical Data for Efficacy and Safety (Clinical Assessor Course - Self Paced) | This training focuses on critically reviewing clinical data for efficacy and safety, applying evidence-based practice principles to regulatory assessment. It... | [Link] | Registration Required Self-paced | Africa | Free |
| 1599 | Clinical data clinical endpoints and outcomes (Clinical Assessor Course - Self Paced) | This training introduces the principles of clinical endpoints, surrogates, and biomarkers, exploring how they relate to therapeutic indications and labeling.... | [Link] | Registration Required Self-paced | Africa | Free |
| 1598 | Assessment of Validity and Acceptability of Clinical Data for Regulation (Clinical Assessor Course - Self Paced) | This training covers how regulators judge the validity and acceptability of clinical data for decisions. It uses CTD Module 5... | [Link] | Registration Required Self-paced | Africa | Free |
| 1597 | Regulatory Assessment of Relevance of Clinical Data for Indication, Licence and Label (Clinical Assessor Course - Self Paced) | This training focuses on assessing clinical data for therapeutic indication, licence, and labeling. Topics include structured benefit–risk assessment, consistency with... | [Link] | Registration Required Self-paced | Africa | Free |
| 1596 | Interpretation and Reporting of Clinical Data (Clinical Assessor Course - Self Paced) | This lesson covers how clinical trial data is interpreted and reported: statistical hypotheses, efficacy and safety outcomes, estimands and intercurrent... | [Link] | Registration Required Self-paced | Africa | Free |
| 1595 | Collection of Clinical Data – What and How (Clinical Assessor Course - Self Paced) | This lesson outlines what clinical data is collected and how: trial phases, data types and validation, endpoint development, and the... | [Link] | Registration Required Self-paced | Free | |
| 1594 | Clinical Data for Regulation and Product Licensing (Clinical Assessor Course - Self Paced) | This course introduces the regulatory use of clinical data in product development and licensing. It examines how clinical trial and... | [Link] | Registration Required Self-paced | Africa | Free |
| 1593 | Molecule to Market - Overview of Drug Discovery & Development (Clinical Assessor Course - Self Paced) | This course provides an overview of the drug discovery and development process, from identifying unmet medical needs to selecting clinical... | [Link] | Registration Required Self-paced | Africa | Free |
| 1602 | Marketing Authorisation and Product Information (Clinical Assessor Course - Self Paced) | This training addresses marketing authorisation and product information: how clinical evidence is reflected in SmPCs and patient leaflets, and how... | [Link] | Registration Required Self-paced | Africa | Free |
| 1603 | Clinical Data for Regulatory Communications (Clinical Assessor Course - Self Paced) | This training outlines how clinical data are communicated to regulators, clinicians, sponsors, and patients during and after marketing authorisation. It... | [Link] | Registration Required Self-paced | Africa | Free |
| 1604 | Regulators and Sponsors as Partners for Patient Benefit (Clinical Assessor Course - Self Paced) | This training examines how regulators and sponsors work together across the product life cycle. It covers drivers on both sides,... | [Link] | Registration Required Self-paced | Africa | Free |
| 1605 | Biosimilars (Clinical Assessor Course - Self Paced) | This training covers core concepts and regulatory frameworks for biosimilars (EMA, FDA, WHO), clinical and PK study design, case studies... | [Link] | Registration Required Self-paced | Africa | Free |
| 1606 | Regulation of Biotherapeutics and Vaccines (Level 1) | The aim of this short learning programme is to introduce course participants to the theory and practice of conducting regulatory... | [Link] | Restricted to Internal Staff | Africa | Free |
| 1607 | EMA Information Day on Submission of Initial MA & Post-Marketing Applications | EMA-led training day on dossier submission, lifecycle & regulatory procedures | [Link] | Registration Required | Europe | Paid |
| 1608 | Extended EudraVigilance Medicinal Product Dictionary Training | Hands-on training on XEVMPD compliance & submission | [Link] | Registration Required | Europe | Paid |
| 1610 | EMA Clinical Trials Information System - Sponsor user training programme | Practical, hands-on training course on CTIS system functionalities including the creation and submission of an initial application, respond to RFIs,... | [Link] | Registration Required | Global | Paid |
| 1612 | Virtual Live Hands-On Training Course for Clinical Trials Sponsors Using The EudraVigilance System | Virtual live training course including EMA required knowledge evaluation, on how to report, view and download ICSRs using the EudraVigilance... | [Link] | Registration Required | Europe | Paid |
| 1613 | EMA Information Day on submission predictability of initial marketing authorisation | The focus of this interactive Information Day will be to enhance a common understanding, raise awareness of the challenges for... | [Link] | Registration Required | Europe | Paid |
| 1614 | eXtended EudraVigilance Medicinal Product Dictionary Training Course | Virtual training course on how to submit and retrieve medicinal product data using EVWEB/ XEVMPD (Art 57 database) for authorised... | [Link] | Registration Required | Europe | Paid |
| 1615 | Mandatory use of ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System | Virtual live training course including EMA required knowledge evaluation, on how to report, view and download ICSRs using the EudraVigilance... | [Link] | Registration Required | Global | Paid |
| 1552 | FDA Clinical Investigator Training Course (CITC) | ABOUT THIS EVENT (Hosted by CDER SBIA) This is a recording (video, audio and slides) of the Annual FDA training... | [Link] | Self-paced | Americas, United States of America | Free |
| 1553 | Data Safety and Monitoring Boards (DSMBs) for Clinical Trials | This course outlines the role of a Data Safety and Monitoring Board (DSMB) during a clinical trial. Appointed by the... | [Link] | Available in other languages | Global | Free |
| 1554 | ICH Good Clinical Practice E6(R3) | Updated GCP course aligned to ICH E6(R3); 8 modules with certificate; relevant for regulators overseeing trials. | [Link] | Available in other languages Self-paced | Global | Free |
| 1536 | Pharmacovigilance (Level 1) | Pharmacovigilance is often considered to be an area of specialization not adequately covered in undergraduate curricula for the purpose of... | [Link] | Restricted to Internal Staff | Africa, South Africa | |
| 1537 | International Conference on Pharmacometrics (ICoP India 2026) | The second annual conference of the Society of Pharmacometrics and Health Analytics (formerly PAGIN), organized by the Centre for Pharmacometrics,... | [Link] | Asia, India | Paid, Scholarships Available | |
| 1517 | Certificate Course on Bioequivalence Analysis in Drug Development | Objectives: This certificate program offers a practical and comprehensive introduction to bioequivalence (BE) analysis in drug development. Designed for professionals... | [Link] | Certification Available Instructor-led Registration Required | Global, India | Paid |
| 1518 | Certificate Course on AI in Drug Development | Objectives Understand the fundamental concepts of machine learning and their applications in drug development use cases. Understand and apply machine... | [Link] | Certification Available Instructor-led Registration Required | Global, India | Paid |
| 1511 | Building and Implementing PBPK Models Webinar | Wednesday, 25 June 202514:00 West African Time Agenda: Verification and Validation of PBPK Models (Part 2) Questions and Answers from... | [Link] | Instructor-led Registration Required | Africa, Nigeria | Free |
| 1498 | Seventh Biennial Scientific Conference on Medical Products Regulation in Africa (SCoMRA VII) | The Scientific Conference on Medical Product Regulation in Africa (SCoMRA) 2025 will be convened under the theme: “Regulatory Harmonisation: “Unlocking... | [Link] | Registration Required | Africa | |
| 1487 | Fundamentals of Physiologically Based Pharmacokinetic (PBPK) Modelling | Last month, we had an introduction to pharmacometrics. Join us as we continue our discussion on PBPK modelling. This webinar... | [Link] | Instructor-led Registration Required | Global | Free |
| 1484 | Exploring the fundamentals of PBPK and Population Pharmacokinetics | PMX Africa: Nigeria ChapterMarch 2025 Webinar Introduction to PBPK and Population PharmacokineticsRecorded: Wednesday, March 26, 2025 This was an insightful... | [Link] | Self-paced | Global | Free |
| 1481 | Mechanistic Absorption Modelling: Enhancing Understanding and Prediction of Drug Performance | About this seriesSharing knowledge, presenting advances and discussing best practices in pharmacometrics, featuring locally-relevant case studies in application of PBPK... | [Link] | Global | Free | |
| 1477 | Digital Health Africa 2025 | The Digital Health Africa Conference (DHA-2024) has successfully showcased progress in digital health, telemedicine, precision medicine, real-world evidence, pharmacometrics and artificial intelligence... | [Link] | Registration Required | Africa | Varies, Discount for LMICs |
| 1251 | Nonlinear Mixed Effects Modeling with Pumas | Join the University of Cape Town chapter of Pharmacometrics Africa for a hands-on workshop focused on Nonlinear Mixed Effects Modeling Workflows... | [Link] | Instructor-led Registration Required | Africa, South Africa | Varies |
| 55 | Pharmacometric Considerations for Guiding Pediatric Trial Designs | Major gaps exist in the ability to appropriately design pediatric clinical trials as well as construct suitable dosing guidance in... | [Link] | Global | Free | |
| 56 | Controlled Human Infection Challenge Studies: Lessons from Malaria towards COVID-19 | Controlled Human Infection Challenge Studies involve the deliberate infection of healthy volunteers to support clinical vaccine development, for example for... | [Link] | Global | Free | |
| 54 | Clinical Pharmacology in Africa - history, progress and lessons learnt | Each year, Pharmacokinetics UK honors the memory of Peter Coates by inviting speakers that are recognized for their contributions to... | [Link] | Africa | Free | |
| 52 | Global Benchmarking Tool for Assessors | This training is developed for WHO assessors using the Global Benchmarking Tool (GBT) to benchmark Regulatory Authorities. In line with... | [Link] | Available in other languages Certification Available Registration Required Self-paced | Global | Free |
| 51 | Good Reliance Practices | The aim of this course is to provide an introduction to WHO Good Reliance Practices (GRelP) and to advocate for... | [Link] | Global | Free | |
| 50 | Vaccine Safety Basics | This course introduces participants to the foundations of vaccine pharmacovigilance. The aim of this course is to provide healthcare professionals... | [Link] | Available in other languages Registration Required Self-paced | Global | Free |
| 49 | Pharmacometrics Self-Paced | These lessons provide a structured overview of clinical pharmacology and pharmacometrics, and is part of a set of training activities... | [Link] | Free | ||
| 57 | Model-informed Drug Repurposing: Applications for COVID-19 | Examine the scientific basis for your COVID-19 study: The global scientific community’s scramble to rapidly find therapeutics for COVID-19 has... | [Link] | Free | ||
| 47 | Cross-Discipline Mathematical Modelling Symposium 2023 | A multidisciplinary discussion about the concepts and applications related to mathematical modelling and simulations. The structure of the event is... | [Link] | Free | ||
| 46 | Digital Health Africa Conference 2024 | This conference served as a platform to address the unique challenges Africans face and to capitalise on the opportunities for... | [Link] | Varies, Discount for LMICs | ||
| 45 | Advanced Pharmacometrics | Prof. Nick Holford has made his substantial (created over a 30+ year career) library of course materials available for public... | [Link] | Global | Free | |
| 44 | Pharmacometrics Training Library | As part of Metrum Institute's continuing efforts to support and grow the discipline of pharmacometrics, we are pleased to announce... | [Link] | Global | Varies | |
| 72 | Bioequivalence and Bioavailability Forum | This is a collection of materials related to bioequivalence set up by Helmut Schütz, a chemical engineer by training who... | [Link] | Global | Free | |
| 71 | The Global Health Network Resource Gateway | A library of hundreds of free and open access resources found across the whole of The Global Health Network. This... | [Link] | Global | Free | |
| 70 | Clinical Investigator Certificate Course (CLIC) | The planning, preparing, and organising of clinical trials have become a highly complex task that includes important issues such as:... | [Link] | Certification Available Instructor-led Registration Required | Africa | Varies |
| 69 | Clinical Assessors Regulatory Short Course | This 13-week University-certified virtual course addresses gaps in regulatory sciences through self-study and live tutorials by subject matter experts from academia,... | [Link] | Instructor-led Registration Required | Africa | Varies |
| 68 | Vienna School of Clinical Research - Short courses Clinical Research | Since its foundation in the year 2000 VSCR has focused on training and education in all relevant topics in Clinical... | [Link] | |||
| 67 | RAPS online university | The RAPS Online University offers certificate courses in two tracks—pharmaceuticals and medical devices. The Regulatory Affairs Certificate Program is an... | [Link] | Varies | ||
| 66 | EMA Training opportunities for non-EU regulators | The European Medicines Agency (EMA) supports non-European Union (EU) regulators by organising dedicated awareness sessions to provide them an insight into... | [Link] | Self-paced | Global | Free |
| 65 | PharmaTrain resource library | Abstract: PharmaTrain is a network of public and private partners that aim to develop and make available education and training... | [Link] | |||
| 64 | Building Capability for Clinical Pharmacology Research in Sub-Saharan Africa | Abstract: A strong scientific rationale exists for conducting clinical pharmacology studies in target populations because local factors such as genetics,... | [Link] | Global | Free | |
| 63 | Needs-driven talent and competency development for the next generation of regulatory scientists in Africa | Abstract: Capacity building programmes for African regulators should link education, training and research with career development in an approach that... | [Link] | |||
| 62 | Clinical Pharmacology Worldwide: A Global Health Perspective | Abstract: Capacity building programmes for African regulators should link education, training and research with career development in an approach that... | [Link] | Africa, Ghana, Global, South Africa, Zimbabwe | Free | |
| 61 | Pharmacometrics: opportunity for reducing disease burden in the developing world: the case of Africa | Abstract: Pharmacometricians are virtually nonexistent in Africa and the developing world. The unrelenting burden of infectious diseases, which are often... | [Link] | |||
| 60 | Non-Compartmental Analysis Webinar | The first step of any PK/PD data analysis is to look at the data on hand and generate insights. The... | [Link] | |||
| 58 | Malaria Vaccine Webinar – Pharmacometrics Africa launch | If we were to develop a second-generation malaria vaccine, what product qualities should be adjusted to improve protection?This webinar commences... | [Link] | |||
| 59 | Principles of ensuring data integrity | Have you ever lost data or have someone who worked on a project leave and take their knowledge of the... | [Link] |