Medical Device Quality Management: CAPA Systems
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Download Thursday, April 09, 2026 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
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Free Trial CoursesOutline: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 | Objectives: | |
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