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

Contact

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