GMP Regulation Handbook: Quality Risk Management, ICH Q9
Guidance for Industry, Q9 Quality Risk Management
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER)
The ICH Q9 regulation handbook is used in association with several ISPE training courses:
- Biotechnology Manufacturing Facility Design Training Course (T31)
- Commissioning and Qualification Training Course (T40)
- Quality Risk Management Workshop (T42)
- Turning QbD into a Practical Reality Training Course (T43)
- Process Validation Training Course (T46)
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