New Course on Preparing the CMC Section for MAAs-IMPDs

Malvern, PA – January 16, 2017 - The Center for Professional Innovation and Education (CfPIE), the global leader of technical training across the life sciences industry, has introduced a new course on Preparing the CMC Section for the Medicare Modernization Act and Investigational Medicinal Product Dossier by Laura Millichamp.

This course includes an assessment of the relevant guidelines and the organization of the CTD, detailed information and discussions related to each element required in the drug substance and drug product sections of MAAs. The course will emphasize the requirements related to drug substance starting materials, drug substance and drug product specifications, impurities, stability, manufacturing and pharmaceutical development. It will also discuss the use of Drug Master Files (DMF), Certificates of Suitability (CEPs) and preparation of the CTD Quality Overall Summary (Module 2).

Laura Millichamp is responsible for the management of projects involving the development of Chemistry Manufacturing and Controls (CMC). She provides scientific, technical and regulatory expertise and is involved in reviewing and preparing regulatory pharmaceutical documents: CMC sections of IMPD/IND, briefing packages for Scientific Advice, variations, CTD module 3, and the Quality Overall Summary of MAAs.

You can find more information on this and other courses offered by The Center for Professional Innovation and Education here