Curriculum
- 8 Sections
- 29 Lessons
- 1 Day
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- Introduction to Quality Risk Management4
- QRM Process Overview3
- 2.1Steps of the QRM process: Risk Identification, Risk Analysis, Risk Evaluation, Risk Control, and Risk Review.Steps of the QRM process: Risk Identification, Risk Analysis, Risk Evaluation, Risk Control, and Risk Review.
- 2.2Tools and techniques: FMEA (Failure Mode and Effects Analysis), Fishbone Diagram, HACCP, and Risk Ranking.
- 2.3Case study on selecting the right tool for a specific pharmaceutical scenario.
- Risk Assessment in Pharma Operations3
- Risk Control and Mitigation Strategies4
- Risk Management in Key Pharma Areas4
- 5.1Application of QRM in manufacturing: Validation, equipment qualification, and process changes.
- 5.2QRM in product lifecycle management: R&D to commercial production.
- 5.3Risk assessment in QC: Stability studies, OOS (Out of Specification), and laboratory deviations.
- 5.4Activity: Team-based analysis of real-world risk scenarios (e.g., contamination event or supply chain disruption).
- QRM in Regulatory Inspections4
- Continuous Risk Review and Monitoring4
- Case Studies and Best Practices3