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
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1. Understanding the Pharmaceutical Quality SystemLocked
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2. PIC/S Expectations for the PQSLocked
Module 2: Management Responsibility
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1. Senior Management ResponsibilitiesLocked
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2. Quality Policy and Quality ObjectivesLocked
Module 3: Quality Risk Management
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1. Introduction to Quality Risk ManagementLocked
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2. Applying QRM Within the PQSLocked
Module 4: CAPA & Change Management
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1. CAPA Within the PQSLocked
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2. Change ManagementLocked
Module 5: Product Quality Review & Performance Monitoring
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1. Product Quality ReviewLocked
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2. Quality Metrics and TrendingLocked
Module 6: Management Review & Continual Improvement
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1. Management ReviewLocked
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2. Continual ImprovementLocked