Out of Specification Management

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Course Content

Module 1: Introduction of Out of Specifications
  • 1. Lesson 1: Introduction of out of Specification
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Module 2: Regulatory Expectations for OOS investigations
  • 2. lesson 1: Regulatory Expectations
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Module 3: Type of Out of Specifications Results
  • 3. Lesson 1: Types of Out of Specification Results
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Module 4: Initial OOS Assessment Phase-1
  • 4. Lesson 1: Initial OOS Assessment Phase-1
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Module 5: Laboratory Investigation - Data Review Phase-1
  • 5. Lesson 1: Laboratory Investigation - Data Review Phase-1
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Module 6: Full Phase-II Investigations
  • 6. Lesson 1: Full Phase-II investigation
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Module 7: Root Cause Analysis
  • 7. Lesson 1: Root Cause Analysis
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Module 8: Re-testing and Re-sampling
  • 8. Lesson 1: Re-testing and Re-sampling
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Module 9: Batch Disposition Decision
  • 9. Lesson 1: Batch Disposition Decision
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Module 10: CAPA Management
  • 10. Lesson 1: CAPA Management
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Module 11: Documentation Trending
  • 11. Lesson 1: Document Trending
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Module 12: Inspection Readiness Case Studies
  • 12. Lesson 1: Inspection Readiness Case Studies
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Final Assessment
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