Module232025

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

Quality (CMC) Development Considerations

The Organisation for Professionals in Regulatory Affairs