GMP Data Integrity Fundamentals

Module 1: Course Introduction

• 1. Lesson 1: Course Overview
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Module 2: Introduction to Data Integrity

• 2. Lesson 1: What is Data Integrity?
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• 3. Lesson 2: Why Data Integrity Matters
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• 4. Lesson 3: Regulatory Expectations
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Module 3: ALCOA+ Principles

• 5. Lesson 1: Attributable
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• 6. Lesson 2 Legible
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• 7. Lesson 3: Contemporaneous
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• 8. Lesson 4: Original
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• 9. Lesson 5: Accurate
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• 10. Lesson 6: The Plus in ALCOA+
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Module 4: Good Documentation Practices

• 11. Lesson 1: Good Documentation Practices
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• 12. Lesson 2: Corrections and Changes
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• 13. Lesson 3: Real-Time Recording
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Module 5: Audit Trails and Electronic Records

• 14. Lesson 1: What is an Audit Trail?
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• 15. Lesson 2: Audit Trail Review
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• 16. Lesson 3: Electronic Records and Signatures
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Module 6: Common Failures and Inspection Readiness

• 17. Lesson 1: Common Data Integrity Failures
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• 18. Lesson 2: FDA 483 and Warning Letter Themes
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• 19. Lesson 3: Inspection Readiness
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