Quality Management - WHO GMP

This course is updated and enhanced to align with current regulatory expectations (ICH Q10, WHO GMP, EU GMP, FDA guidance), including: Clear hierarchy of Quality Management, Quality Assurance, GMP, and Quality Control Detailed QA system requirements (design, control, release, storage, distribution, self-inspection, change control, continuous improvement) Manufacturer's responsibility for safety, efficacy, and quality Basic GMP requirements (resources, documentation, validation, complaints, recalls) Updated case studies and common deficiencies

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Course Content

Module 1: Introduction
  • 1. Lesson 1: Introduction
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  • 2. Lesson 2: Learning Objectives
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  • 3. Lesson 3: Quality Relationships
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  • 4. Lesson 4: Philosophy and Elements
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  • 5. Lesson 5: Management Tools
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Module 2: Requirements
  • 1. Lesson 1: Principles of Quality Assurance
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  • 2. Lesson 2: QA System Requirements – Part 1
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  • 3. Lesson 3: QA System Requirements – Part 2
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  • 4. Lesson 4: QA System Requirements – Part 3
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  • 5. Lesson 5: Manufacturer Responsibilities for Quality
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Module 3: Implementation and Requirements
  • 1. Lesson 1: Implementing Quality Assurance
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  • 2. Lesson 2: Basic GMP Requirements
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  • 3. Lesson 3: Resource and Validation
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  • 4. Lesson 4: Documentation and Operation
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  • 5. Lesson 5: Case Studies
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Module 4: Common Issues
  • 1. Lesson 1: Common GMP Issues Part-1
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  • 2. Lesson 2: Common GMP Issues Part-2
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  • 3. Lesson 3: Action Planning
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  • 4. Lesson 4: Key Takeaways
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Final Assessment
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