Advanced CMC Requirements for Generics Applications

Advanced CMC Requirements for Generics Applications is a specialized live online training course designed for pharmaceutical and regulatory professionals seeking expertise in Chemistry, Manufacturing and Controls (CMC) for generic medicines. The programme covers CTD Module 3, API and drug product dossiers, DMFs, ASMFs, CEPs, process validation, technology transfer, lifecycle management, and the latest ICH, EMA, and FDA guidelines, with interactive sessions and a Certificate of Completion.

Certificate of Completion; hands-on examples and case studies; access to course materials.

Professionals seeking expertise in pharmaceutical regulatory science and related fields.