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. Participants will gain practical knowledge of 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. Led by industry expert Dr. Helmut Vigenschow, the programme features interactive sessions, real-world case studies, hands-on examples, networking opportunities, comprehensive course materials, and a Certificate of Completion.