This twelve-hour course will provide International Council for Harmonization (ICH) and World Health Organization (WHO) guidelines related to vaccine manufacturing and other sterile biologics, including manufacturing process controls and pharmaceutical validation. Guidance on USP standards in vaccine production will also be covered. Participants will engage in practical hands on exercises and case studies to reinforce key learning points.
Subject area:
Biologics
Objectives (If applicable):
•Identify and discuss the main good manufacturing practice (GMP) principles for pharmaceutical products and the pharmaceutical quality system according to the World Health Organization (WHO)
•Summarize and discuss the main recommendations of WHO TRS 996, Annex 5, WHO TRS 961, Annex 6 and TRS 992, Annex 3
•Identify the impact of critical changes to product quality through practical application and exercises
•Describe the lifecycle approach and expectations for GMP production of biological products according to the WHO
•Demonstrate proficient knowledge of validation principles according to the World Health Organization
•Identify and describe the main aspects and approach of the FDA Guidance for Industry Process Validation
•Summarize and discuss critical aspects related to control of equipment, processes, and premises as it relates to validations
•Identify GMP principles according to ICH Q7 and USP general chapters for vaccines and biological products
•Summarize and discuss ICH Q9 and Q10 guidance
•Describe viral safety during manufacturing of vaccines according to ICH guidelines and USP General Chapters
Target Audience (If applicable):
•R&D Cell Biologists
•R&D Manufacturers
•Research Scientists
•Biotechnology Manufacturers
•Pharmaceutical Microbiologists