Description
This module will enable you to identify and interpret the requirements of a pharmaceutical CAPA system. CAPA is a fundamental management tool that is integral to an effective quality management system.
Course Objectives
Students completing this course should be able to:
- Identify the regulatory requirements for a CAPA system
- List the various phases and the processes of a successful CAPA system
- Explain the critical elements of a CAPA system
- Explain the importance of risk assessment and investigation
- Describe tracking and escalation processes in a CAPA system
- Recognize the requirements of ICH Q10 - Pharmaceutical Quality System (PQS)
Course Outline
INTRODUCTION
1. Welcome
2. Introduction
3. Overview
4. Pharmaceutical Quality System (PQS) Model
5. Key areas of the QMS
6. Reviews and assessments
REGULATIONS
7. Overview
8. Compliant CAPA systems
9. Activity: Looking for CAPA requirements within GMPs
10. FDA QSIT inspections of CAPA systems
11. Important definitions
12. Examples of different CAPAs
13. Topic review
THE CAPA SYSTEM
14. Overview
15. Features of a CAPA system
16. CAPA flowchart
17. Phases of a CAPA system
18. Topic review
ELEMENTS OF CAPA SYSTEMS
19. Overview
20. CAPA system inputs
21. Risk assessment and CAPA
22. Risk assessment process
23. CAPA documentation
24. The CAPA procedure
25. CAPA request/record
26. Correction/containment
27. Corrective action
28. Preventive action
29. Verification and closeout
30. Completed CAPA report
31. Topic review
ROOT CAUSE ANALYSIS
32. Symptom or Root Cause?
33. When to conduct RCA/CAPA
34. Root Cause Analysis (RCA)
35. Investigation & Analysis
TRACKING AND ESCALATION
36. Overview
37. Progress tracking and escalation
38. CAPA trending
39. Topic review
CONCLUSION
40. Summary