This module aims to equip the learners with a well-rounded understanding of ATMP development and manufacturing.

This blended course of 5 days of theory and NIBRT onsite practicals combines theoretical sessions blending comprehensive regulatory knowledge with hands-on technical experience, to ensure it equips the attendees with the skills and insights required to excel in ATMP production and compliance. The course emphasises regulatory frameworks, quality systems, risk management and cleanroom operations, ensuring learners gain both theoretical and practical expertise.

1. Critically evaluate and apply ATMP manufacturing principles in compliance with relevant regulatory frameworks, including EU GMP Annex 1, FDA guidelines, and ATMP-specific regulations.
2. Implement GxP principles, draft and evaluate GMP compliant SOPs and conduct risk assessments effectively.
3. Critically apply contamination control strategies and advanced aseptic techniques within cleanroom environments, demonstrating mastery of industry best practices.
4. Assess and implement appropriate QC techniques, including sterility, endotoxin testing, and flow cytometry, to ensure product integrity and regulatory compliance.
5. Troubleshoot issues within manufacturing processes with confidence and develop teamwork, critical thinking, problem-solving and troubleshooting skills in real-world scenarios.