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PIC/S Qualification & Validation

PIC/S qualification and validation principles, planning, equipment and facility qualification, process validation, cleaning validation, and maintenance of the validated state.

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Course Content

Module 1: Qualification & Validation Fundamentals
  • 1. Understanding Qualification and Validation
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  • 2. PIC/S Annex 15 Overview
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Module 2: Validation Planning & Documentation
  • 1. Validation Master Planning
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  • 2. Requirements, Protocols & Reports
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Module 3: Equipment & Facility Qualification
  • 1. Qualification Stages
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  • 2. OQ & PQ
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Module 4: Process Validation
  • 1. Process Validation Fundamentals
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  • 2. Process Validation Lifecycle
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Module 5: Cleaning & Other Validation Activities
  • 1. Cleaning Validation
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  • 2. Other Validation Areas
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Module 6: Maintaining the Validated State
  • 1. Change Control & Requalification
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  • 2. Continued Control
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Final Assessment
Complete all modules to unlock final exam
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