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
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