This course is a blended learning opportunity during which participants will engage in self-paced modules and live virtual education to learn about PCM over a course of four weeks.
Learners will:
Participate in an online, introductory session detailing parameter of the course and covering such topics as “What Is Continuous Manufacturing?” and reviewing the benefits in cost, robustness and integration of PCM for optimizing product and process development.
Explore an array of self-paced modules (video and e-learning) covering PCM topics such as:
Material Properties
Unit Ops: Feeders, Blenders and Tablet Press
Residence Time Distribution (RTD), Process Analytical Technologies (PAT) and Control Considerations
Flow Sheet Modeling and Line Integration
Engage with experts in the areas of pharmaceutical continuous manufacturing through a mid-course town hall virtual live event and an online Q&A forum throughout program.
Experience a virtual lab walkthrough that demonstrates the PCM line in action.
Apply new knowledge to PCM case studies at a virtual live event.
Subject area:
cGMP
Drug Products & APIs
Objectives (If applicable):
Explain the following in detail: a PCM line; optimal applications, processes and procedures for instituting a PCM line; and material properties, modes and test methods that are applicable in PCM.
Identify the RTD, PAT and control considerations necessary for proper PCM line operation.
Explain components and operations of feeders, blenders and tablet presses in PCM.
Analyze the use of flow sheet modeling and line integration, including unit ops models, sensitivity, and feasibility analysis and optimization.
Apply knowledge of the line processes, operations, tools and procedures to problems and scenarios related to PCM.
Target Audience (If applicable):
Pharmaceutical manufacturing Research & Development scientists and engineers, formulators, PAT scientists, technical services, line operators and QA specialists
Pharmaceutical technology supplier representatives in equipment, instrumentation, ingredient and process controls
Representatives from regulatory agencies and consulting companies