Module 3 Presentations

07/05/2024

Setting up the CMC Function for Success INNOVATIONS CHALLENGING REGULATIONS

Tailoring the CMC Setup - focus on three things: (1) Improve capabilities with respect to regulatory relationships, QbD and analytical technologies (2) Seamless handoffs (of integrated teams) between research and CMC, and manufacturing (3) Product-focused cross-functional teams (4) Integrate regulatory input and QbD early in the process of defining CMC strategies and plans

CMC Project Management

The Organisation for Professionals in Regulatory Affairs

39

CMC Project Management

The Organisation for Professionals in Regulatory Affairs

40