COURSE OUTLINE
INTRODUCTION
1. Welcome
2. Course objectives
3. Assessment
OVERVIEW OF RISK MANAGEMENT
4. Glossary of terms
5. Regulatory standards and guidance
6. ISO 14971:2007
7. The concept of risk
8. Risk management process
9. Roles and responsibilities
10. Example of a Hazards and Consequences Analysis
11. Review
RISK MANAGEMENT PROCESS
12. Introduction
13. Risk management planning
14. Probability and severity descriptors
15. Risk analysis
16. Risk evaluation tools
17. Risk estimation and classification
18. Risk mitigation
19. Risk control
20. Post-production information
21. Documentation
22. Review
CONCLUSION
23. Summary
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COURSE OBJECTIVES
Students completing this course should be able to:
- Explain the terminology of risk management
- Identify the risk management processes
- Identify how risk can be calculated
- Identify the documentation required for risk management
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