Gain insight on functions and pathways involved in product development, including the purpose and conduct of clinical trials in Phases I, II, and III. Better understand how decisions during drug development (i.e., dosage forms, batch size, production method, outsourcing) impact product lifecycle viability and success, and why physical and chemical attributes of products have implications in production. Also review the production process and the role of interactions of ingredients/materials employed in pharmaceutical development and manufacturing, as well as the impact of processing, storage, and transport environments on ingredients/materials and semi- and finished goods. At the conclusion of this online course, participants will have knowledge of:
Attendance suggested for:
Charles F. Carney has nearly 40 years of experience in pharmaceutical drug product development, manufacturing, and analytical control. His industrial experience was gained at Wyeth (formerly Ayerst Laboratories) and Boehringer Ingelheim. For the last 15 years of his corporate service, he was the associate director of investigational supplies in the Connecticut R&D Center of Boehringer Ingelheim. Since 2003 he has been a consultant for Seraphim Life Sciences Consulting, LLC. His responsibilities have included performing and managing pharmaceutical, analytical, and GMP compliance aspects of drug product development, including the outsourcing, validation, and technology transfer aspects and the quality control, and facility design for commercial drug products. He is a member of ISPE, ACS, and AAAS. He has published and presented papers extensively in the areas of pre-formulation, formulation, and control of manufacturing operations for clinical drug products. He also has published and presented concepts in the areas of outsourcing of manufacturing and control, and for optimizing international operations. He is a co-editor of the second edition of “Drug Products for Clinical Trials” (Taylor & Francis, 2006).