MD-Q 4: Corrective and Preventive Action (CAPA) Systems

Description: The ability to identify and correct existing problems and implement controls to prevent potential problems is essential for continued customer satisfaction, safe products, and efficient quality management processes. This module will introduce you to the requirements of a CAPA system.

Price: $209 (AUD)

INTRODUCTION
1. Welcome
2. Introduction
3. Overview
4. Key areas of the QMS
5. Reviews and assessments

REGULATIONS
6. Overview
7. Compliant CAPA systems
8. FDA QSIT inspections
9. Important definitions
10. Examples of different CAPAs
11. Topic review

THE CAPA SYSTEM
12. Overview
13. Features of a CAPA system
14. CAPA flowchart
15. Phases of a CAPA system
16. Topic review

ELEMENTS OF SUCCESSFUL CAPA SYSTEMS
17. Overview
18. CAPA system inputs
19. Risk assessment and CAPA
20. Risk assessment process
21. CAPA documentation
22. The CAPA procedure
23. CAPA request/record
24. Correction/containment
25. Investigation & analysis
26. Corrective action
27. Preventive action
28. Verification and closeout
29. Completed CAPA report
30. Topic review

TRACKING AND ESCALATION
31. Overview
32. Progress tracking and escalation
33. CAPA trending
34. Topic review

CONCLUSION
35. Summary

• 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

SeerPharma is grateful for the endorsement of the DISCover Medical Devices series by:

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