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