GMP Data Integrity Fundamentals

Practical GMP data integrity training covering ALCOA+, audit trails, documentation practices, and inspection readiness.

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Course Content

Module 1: Introduction to Data Integrity
  • 1. What is Data Integrity?
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  • 2. Why Data Integrity Matters
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  • 3. Regulatory Expectations
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Module 2: ALCOA+ Principles
  • 4. Attributable
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  • 5. Legible
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  • 6. Contemporaneous
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  • 7. Original
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  • 8. Accurate
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Module 3: Good Documentation Practices
  • 9. Good Documentation Practices
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  • 10. Corrections and Changes
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  • 11. Real-Time Recording
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Module 4: Audit Trails and Electronic Records
  • 12. What is an Audit Trail?
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  • 13. Audit Trail Review
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  • 14. Electronic Records and Signatures
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Module 5: Common Failures and Inspection Readiness
  • 15. Common Data Integrity Failures
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  • 16. FDA 483 and Warning Letter Themes
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  • 17. Inspection Readiness
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