Single Use System Qualification and Validation
Module Lenght
1 day
Agenda
- International Regulatory Context
- Requirements (PDA, EMEA and FDA)
- Material Qualification Documentation
- Single Use Equipment Process Validation Requirements
- Process Validation Studies
- Process Review
- Validation Test Overview
- Compatibility
- Adsorption
- Extractables & Leachables
- Stability Studies
- Toxicological Risk Assessment
- Bracketing and Grouping
- Process Revalidation
- Future Regulatory Trends
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
- ICH Q7
- USP <87>,<88>,<660>,<661>,<1660>, <1663>,<1664>
- PDA TR 66 ” Application of Single-Use Systems in Pharmaceutical Manufacturing”
- PQRI publication: Safety thresholds and best practices for extractables and leachables in Orally Inhaled and Nasal Drug Products
- ASTM E2097-00 (2006): Standard guide for determining the impact of extractables from non-metallic materials on the safety of Biotechnology Products
Number of trainers
One/Two
Tailoring option available
Yes
Final evaluation quiz
Yes