Deviation, Investigation, CAPA, and Root Cause Analysis Training
A practical GMP course covering deviations, investigations, root cause analysis, CAPA development, effectiveness checks, and inspection readiness.
Free
Course Access
Free course available.
Start Course
Course Content
Module 1: Introduction to Deviations and Investigations
-
1. Lesson 1: What is a Deviation?
-
2. Lesson 2: Why Investigations Matter in GMP
-
3. Lesson 3: Quality System Linkages
Complete lessons to unlock quiz
Module 2: Deviation Identification and Classification
-
4. Lesson 4: Planned vs Unplanned DeviationsLocked
-
5. Lesson 5: Minor, Major, and Critical ClassificationLocked
-
6. Lesson 6: Immediate Actions and ContainmentLocked
Complete lessons to unlock quiz
Module 3: Investigation Process and Documentation
-
7. Lesson 7: How to Structure an InvestigationLocked
-
8. Lesson 8: Data Gathering and Evidence ReviewLocked
-
9. Lesson 9: Investigation Writing Best PracticesLocked
Complete lessons to unlock quiz
Module 4: Root Cause Analysis Tools and Techniques
-
10. Lesson 10: 5 WhysLocked
-
11. Lesson 11: Fishbone DiagramLocked
-
12. Lesson 12: Human, Process, Equipment, and System FactorsLocked
Complete lessons to unlock quiz
Module 5: CAPA Development and Implementation
-
13. Lesson 13: Corrective Action vs Preventive ActionLocked
-
14. Lesson 14: Writing Strong CAPAsLocked
-
15. Lesson 15: Ownership, Due Dates, and Execution TrackingLocked
Complete lessons to unlock quiz
Module 6: Effectiveness Checks and Closure
-
16. Lesson 16: When to Perform Effectiveness ChecksLocked
-
17. Lesson 17: How to Verify CAPA EffectivenessLocked
-
18. Lesson 18: Closure Requirements and DocumentationLocked
Complete lessons to unlock quiz
Module 7: Regulatory Expectations and Inspection Readiness
-
19. Lesson 19: FDA and EU GMP ExpectationsLocked
-
20. Lesson 20: Common 483 and Inspection FindingsLocked
-
21. Lesson 21: Best Practices for Sustainable ComplianceLocked
Complete lessons to unlock quiz