Course Overview:
Enhanced with Interactive Cleanroom Augmented Virtual Reality Demonstrations
Contamination control is a core requirement in all GMP-regulated environments, applying to the handling, storage, and processing of both sterile and non-sterile materials and products. Global regulations such as PIC/S PE 009-17 and FDA 21 CFR Part 211 contain extensive requirements aimed at preventing contamination, highlighting its critical role in protecting product quality and patient safety.
This course provides a practical, streamlined understanding of contamination risks and the controls needed to manage them effectively. Through case examples and guided discussions, participants will learn how to identify contamination sources, apply risk-based controls, and implement procedures consistent with current GMP expectations.
Key Learning Outcomes
• Understand the importance of contamination control in relation to GMP and product quality
• Review key regulatory expectations from PIC/S and FDA
• Identify contamination types and common sources
• Learn practical strategies to prevent and control contamination
• Apply cleaning and sanitation principles effectively
• Gain exposure to cleanroom operations and environmental control requirements
• Understand how to set alert/action limits for environmental monitoring
• Strengthen contamination control programs through real-world examples.
Course Outline:
Day 1 — Contamination Control Essentials
• GMP principles on contamination prevention
• Types of contamination & major sources
• Risk assessment for contamination hazards
• Practical contamination control strategies
• Cleaning & sanitation fundamentals
• Choosing disinfectants and applying cleaning techniques
Day 2 — Cleanroom & Environmental Control
• Cleanroom operations, facility design, HVAC basics
• International cleanroom standards
• Gowning, operator behaviour, and qualification
• Cleanroom discipline & operational controls
• Environmental Monitoring: alert/action limits, methods, and examples
• Cleanroom classification & controlled environment design
• Common GMP deficiencies and how to avoid them
Participants
Ideal for Operators, Supervisors, Officers, and Managers across Production, Packaging, QA, QC, Engineering, and other GMP-regulated departments seeking a solid understanding of contamination control and cleanroom operations.