Quality Risk Management
Module Lenght
half a day to 1 day
Agenda
- Regulatory background (in detail ICH Q9 “Quality Risk Management”, EU GMP Part III Q9)
- QRM methodology following FMEA
- QRM case study 1: Water Systems
- QRM Case study 2: Commissioning & Qualification activity
Target audience
- Quality Assurance
- Validation
- Engineering
Learning tools
- Presentations
- Lectures
- Case Studies
- Discussion
- Question & Answers session
- Final Evaluation Test
Regulatory & technical references
- EU GMP Part III Q9 “”Quality Risk Management (ICH Q9)”
- “ICH Q9 “QUALITY RISK MANAGEMENT”
- IEC 60812 “Analysis techniques for system reliability – Procedure for failure mode and effects analysis (FMEA) “
- ISPE – Baseline Vol. 7 “Risk-Based Manufacture of Pharmaceutical Products”
- WHO TRS 981, Annex 2 “WHO guidelines on quality risk management”
- PDA – TR 54-3 “Implementation of Quality Risk management for Pharmaceutical and Biotechnology Manufacturing Operations – Annex 2: Case studies in the Manufacturing of Pharmaceutical Drug Products”
Number of trainers
One
Tailoring option available
Yes
Final evaluation quiz
Yes