OUR COURSES

Quality risk management

Course Details

Module length  
1 day
Learning tools  
Presentations, Lectures, Case Studies 
Discussion, Question & Answers session, Final Evaluation Test

 

Target audience  
Quality Assurance, Validation, Engineering

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

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”
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