About
The Contamination Control Fundamentals Program is a structured training designed to equip pharmaceutical professionals with essential knowledge in contamination control and regulatory compliance. It covers key areas of contamination prevention, risk management, and regulatory expectations to ensure GMP compliance. Program Modules: CCS Program Overview – Introduction to contamination control, industry trends, and compliance challenges. Contamination Control Introduction (Parts 1-4) – Covers contamination fundamentals, bioburden/endotoxin monitoring, facility design, personnel training, equipment maintenance, and CAPAs. Contamination Control Strategy Creation – Development of a robust Contamination Control Strategy (CCS), identifying contamination sources, and implementing preventive measures. Quality Risk Management & RCA Tools – Application of Quality Risk Management (QRM) per ICH Q9, risk assessment, and - Root Cause Analysis (RCA) tools. Understanding Contamination Risks – Microbial, particulate, and chemical contamination sources and mitigation strategies. EU Annex 1 Updates – Latest regulatory updates emphasizing a holistic CCS for sterile manufacturing. Sources of Particulate & Microbial Contamination – Identification, monitoring, and control of contamination risks. Industry Compliance Risks – Case studies on regulatory findings, FDA warning letters, and contamination-related compliance failures. This program ensures GMP compliance, reduces contamination risks, and enhances product safety. For expert guidance, contact Pharmalliance Consulting Ltd at www.pharmalliance.ie.