Tech Transfer for Biopharmaceutical Manufacturing - Day 3Friday, 7 November 2025

• Regulatory Requirements / Guidance
• Tech transfer and Change control,
• Regulatory implications and product comparability
• Procedure, Protocol , Report: needs and functions
• Essential components of procedure / protocols and reports: donor and acceptor sites; roles and responsibilities; resources ; documentation received and created; identification of changes ; points to consider systematically ; dealing with analytics ; planning ; success / acceptance criteria risk management.

Group exercise (based on case study) outline a TT protocol and detail a paragraph you believe to be critical for this project.