About
This fundamental training program is a targeted training program designed to enhance a company's contamination control capabilities, ensuring compliance with FDA, EMA, WHO, and PIC/S regulations. Course Modules: 1. Overview – Introduction to contamination control, regulatory expectations, and Contamination Control Strategy (CCS). 2. Facility & Cleanroom Risks – Design, maintenance, environmental monitoring, and personnel movement control. 3. Particulate Contamination – Airborne and material-based contamination sources, airflow control, and filtration strategies. 4. Microbial Contamination – Types, sterility assurance, and cleaning validation. 5. Compliance Risks – Regulatory findings and risk management. Key Takeaways: 1. Develop a holistic understanding of Contamination Control Fundamentals. 2. Implement proactive risk management through facility design and personnel training. 3. Reduce regulatory risks and foster a contamination control culture. For expert support, contact Pharmalliance Consulting Ltd at www.pharmalliance.ie.