GMP fundamentals
This foundational course translates the regulatory requirements of Good Manufacturing Practices (GMP) into practical, everyday principles. Participants will move beyond memorizing rules to understanding the "why" behind them, enabling informed decision-making and robust quality culture in roles spanning manufacturing, quality control, warehousing, and engineering.
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500.00 USD
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Course Lessons
1. Module 1: The Pillars of GMP - The Core Systems
1.1 The Quality Management System (QMS): The Umbrella
1.2 Documentation & Records: The "Say What You Do" Pillar
1.3 Personnel & Training: The "Do What You Say" Pillar
1.4 Premises & Equipment: The Foundation
2. Module 2: Controlling the Core Elements
2.1 Materials Management: From Warehouse to Patient
2.2 Production & In-Process Controls
2.3 Packaging & Labelling: The Final Guard
3. Module 3: Verification & Assurance
3.1 Quality Control Laboratories
3.2 The Role of Quality Assurance
4. Module 4: Dealing with Imperfection & Change
4.1 Deviations & CAPA
4.2 Change Management
5. Module 5: Special Topics & The Big Picture
5.1 Cross-Contamination & Cleaning Validation
5.2 Data Integrity in a GMP Context
5.3 The GMP Mindset & Culture
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