About
TheContamination Control Program: Quality Assurance program provides dedicated training on contamination risk assessments, mitigation strategies, and regulatory compliance, ensuring adherence to EU GMP, Annex 1, and ATMP guidelines. Program Modules: EU Annex 1 Risk Assessments – Understanding risk assessment requirements for sterile manufacturing and contamination control. Microbial Control FMEA Risk Assessment – Applying Failure Mode and Effects Analysis (FMEA) to microbial contamination risks. Measures to Mitigate Contamination Risks – Strategies for minimizing microbial, particulate, and cross-contamination. Regulatory Requirements – Compliance with EU GMP, FDA, and EMA guidelines, including Annex 1 and ATMP-specific regulations. EU ATMP Guidelines Part 1 – Overview of Advanced Therapy Medicinal Products (ATMPs), covering sterility, environmental controls, and contamination prevention. EU ATMP Guidelines Part 2 – ATMP-specific manufacturing challenges, risk-based contamination control, and GMP compliance. Future Trends and Advancements – Emerging technologies in contamination control, risk assessment, and regulatory expectations. CCS Implementation Plan – Developing a Contamination Control Strategy (CCS) with a focus on risk-based decision-making and continuous improvement. This program enhances contamination control expertise, ensures regulatory compliance, and reduces contamination risks in sterile and ATMP manufacturing. For expert guidance, contact Pharmalliance Consulting Ltd at www.pharmalliance.ie.