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PIC/S Self-Inspection & GMP Inspection Readiness

PIC/S GMP principles for self-inspection programs, inspection planning and execution, findings, CAPA, regulatory inspection readiness and continuous improvement.

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Course Content

Module 1: Self-Inspection Fundamentals
  • 1. Understanding Self-Inspection
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  • 2. PIC/S Self-Inspection Requirements
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Module 2: Planning the Self-Inspection Program
  • 1. Self-Inspection Planning
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  • 2. Self-Inspection Team
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Module 3: Conducting the Self-Inspection
  • 1. Inspection Techniques
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  • 2. Documents, Interviews & Evidence
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Module 4: Findings, Reports & CAPA
  • 1. Identifying and Reporting Findings
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  • 2. Corrective Action & Follow-Up
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Module 5: Regulatory Inspection Readiness
  • 1. Maintaining Inspection Readiness
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  • 2. During the Regulatory Inspection
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Module 6: Inspection Findings & Continuous Improvement
  • 1. Responding to Inspection Findings
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  • 2. Learning & Continuous Improvement
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Final Assessment
Complete all modules to unlock final exam
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