PIC/S Pharmaceutical Quality System & Management Responsibility

An overview of the PIC/S Pharmaceutical Quality System, management responsibilities, quality governance, and organizational accountability for GMP compliance.

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Course Content

Module 1: Introduction to the Pharmaceutical Quality System
  • 1. Understanding the Pharmaceutical Quality System
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  • 2. PIC/S Expectations for the PQS
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Module 2: Management Responsibility
  • 1. Senior Management Responsibilities
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  • 2. Quality Policy and Quality Objectives
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Module 3: Quality Risk Management
  • 1. Introduction to Quality Risk Management
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  • 2. Applying QRM Within the PQS
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Module 4: CAPA & Change Management
  • 1. CAPA Within the PQS
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  • 2. Change Management
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Module 5: Product Quality Review & Performance Monitoring
  • 1. Product Quality Review
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  • 2. Quality Metrics and Trending
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Module 6: Management Review & Continual Improvement
  • 1. Management Review
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  • 2. Continual Improvement
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Final Assessment
Complete all modules to unlock final exam