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Chapter
- Why was ICH Q9 needed?
- What’s in Quality Risk Management?
- What’s not in ICH Q9 …?
- Q9’s Sample Process
- Different Meanings of “Risk”
- Q9 Approaching Principles
- QRM: Definition
- Tools for Risk Management
- Failure Mode Effect Analysis
- Examples of Implementation: Industry
- Keys to Implementation
- Examples
- QRM Implementation
- INSTRUCTION FOR EVALUATION
- EVALUATION QUESTIONNAIRE
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