This module aims to equip the learners with a comprehensive understanding of ATMP manufacturing workflows and the critical points to assess during facility inspections.

This blended course of 2 days of theory and NIBRT onsite practicals/workshops combines theoretical sessions blending comprehensive knowledge of ATMP production processes, aseptic procedures, equipment, and QC practices with hands-on practical sessions and mock inspections to prepare participants to identify regulatory compliance issue effectively and ensure product safety and quality within ATMP facilities.

Additionally, it caters to regulatory specialists and quality control personnel who play pivotal roles in ensuring compliance and operational excellence within the evolving landscape of ATMPs.

1. Analyse and assess the core components of ATMP development, including production workflows and equipment, while applying an advanced understanding of relevant GMP standards.
2. Apply knowledge of aseptic processing, transfer techniques, and cell culture operations to evaluate compliance.
3. Demonstrate critical insight into the selection and application of analytical and microbiological techniques used in the quality assurance of ATMPs.
4. Collate a structured aide memoire tailored to inspecting ATMP manufacturing facilities.Manage mock inspections effectively, focusing on identifying compliance gaps and ensuring adherence to regulatory standards.
5. Demonstrate expertise in navigating facility audits, inspections, and deviation handling, simulating real-world manufacturing challenges.