Sterilizing Filter Validation
Module Lenght
1 day
Agenda
- International Regulatory Context
- Requirements (PDA, EMEA and FDA)
- Filter and Filtration process definition
- Vendors and User Responsibility
- Process Validation Studies
- Process Review
- Validation Test Overview
- Bacterial Retention Studies
- Compatibility
- Adsorption
- Extractables & Leachables
- Product Wet Integrity Test (PWIT)
- Toxicological Risk Assessment
- Bracketing and Grouping
- Process Revalidation
- Future Regulatory Trends
- Practical Workshop (Optional)
Target audience
- Quality Assurance
- Quality Control
- Regulatory Affairs
- Technology Transfer
- Validation
- R&D
Learning tools
- Presentations
- Lectures
- Case Studies
- Discussion
- Question & Answers session
- Final Evaluation Test
Regulatory & technical references
- Eu cGMP Annex 1
- FDA Guidance for Aseptic Processing
- USP 37 NF 29 <1229>
- ASTM F838
- ICH Q7
- PDA TR 26 “Sterilizing Filtration of Liquids”
Number of trainers
One/Two
Tailoring option available
Yes
Final evaluation quiz
Yes