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PIC/S GMP Documentation & Data Integrity

An overview of PIC/S GMP expectations for documentation, good documentation practices, document control, data integrity, ALCOA+ principles, electronic records, and inspection readiness.

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Course Content

Module 1: GMP Documentation Fundamentals
  • 1. Importance of GMP Documentation
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  • 2. PIC/S Documentation Requirements
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Module 2: Types of GMP Documents
  • 1. Instructions and Procedures
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  • 2. GMP Records
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Module 3: Good Documentation Practices
  • 1. Recording GMP Activities
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  • 2. Corrections and Record Control
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Module 4: Document Control & Lifecycle
  • 1. Document Lifecycle
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  • 2. Controlled Documents
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Module 5: Data Integrity Fundamentals
  • 1. Understanding Data Integrity
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  • 2. ALCOA+ Principles
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Module 6: Electronic Records & Inspection Awareness
  • 1. Electronic GMP Records
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  • 2. Documentation During GMP Inspections
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Final Assessment
Complete all modules to unlock final exam
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