Manufacturing Process Validation for Regulatory Affairs & Process Validation for Sterile Products

Tailored Course Agenda:

Day 1 Live Online: Manufacturing Process Validation:

• Overview of ICH Guidance’s enhanced pharmaceutical development. Covering all Q guidance’s with reference to FDA, EMA and other regulatory considerations
• Overview of the stages of process validation (Process Design, Process Qualification and Continued Process Validation)
• Quality target product profile and Critical Quality Attribute identification
• Analytical target profile, analytical method control strategy and importance of comparability studies
• Process characterization studies, risk assessments (Failure mode and effects evaluation) and identification of critical process parameters
• Process control strategy and demonstration of a process state of control
• Process Performance Qualification (PPQ)
• Continued Process Verification (CPV)
• Equipment Qualification
• Regulatory Readiness and Response

Day 2 Live Online: Process Validation for Sterile Products

• Overview of regulatory expectations for sterile products with particular focus on Annex 1, FDA, and SFDA guidelines
• Importance of a contamination control strategy with special consideration for ATMPS with no terminal sterilization possible
• Terminally Sterilized Drug Products
• Aseptically Filled Drug Products
• Consideration for ATMPS with no terminal sterilization possible: validation of process and utilization of contamination control strategy
• Considerations due to methods of aseptic equipment preparation.
• Considerations related to specific drug delivery methods, Lyophilisation, prefilled syringes and others
• Linking to the overarching process (drug substance / products) and product control strategies, integrating