GMP Documentation Management Training

GMP documentation and data integrity training.

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Course Content

Module 1: Introduction to GMP Documentation
  • 1. Lesson 1: What is GMP Documentation?
  • 2. Lesson 2: Why Documentation is Critical
  • 3. Lesson 3: Types of GMP Records
Module 2: Principles of Good Documentation Practices (GDP)
  • 4. Lesson 4: GDP Fundamentals
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  • 5. Lesson 5: ALCOA Principles Overview
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  • 6. Lesson 6: Dos and Donts of Documentation
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Module 3: Document Types and Lifecycle
  • 7. Lesson 7: SOPs, Batch Records, and Logs
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  • 8. Lesson 8: Document Creation and Approval
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  • 9. Lesson 9: Version Control and Archiving
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Module 4: Controlled Documents and Change Control
  • 10. Lesson 10: Controlled vs Uncontrolled Documents
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  • 11. Lesson 11: Document Change Control Process
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  • 12. Lesson 12: Document Review and Periodic Revision
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Module 5: Data Integrity and ALCOA+ Principles
  • 13. Lesson 13: ALCOA+ Deep Dive
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  • 14. Lesson 14: Electronic vs Paper Records
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  • 15. Lesson 15: Audit Trails and Traceability
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Module 6: Common Documentation Errors and Risk
  • 16. Lesson 16: Common Documentation Errors
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  • 17. Lesson 17: Backdating and Data Manipulation
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  • 18. Lesson 18: Correction and Error Handling
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Module 7: Regulatory Expectations and Inspection Readiness
  • 19. Lesson 19: FDA and EU GMP Expectations
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  • 20. Lesson 20: 483 Observations Related to Documentation
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  • 21. Lesson 21: Best Practices for Audit Readiness
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Final Assessment
Complete all modules to unlock final exam
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