Product Development: Formulation, Clinical Phases, and Manufacturing

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:

  • Functions and pathways involved in product development
  • Purpose and conduct of clinical trials Phases I, II, and III
  • Impact of decisions (for example, dosage forms, batch size, production method, outsourcing) during drug development on product lifecycle viability and success
  • The production process and the role of interactions of ingredients/materials employed in pharmaceutical development and manufacturing
  • Impact of the processing, storage, and transport environments on ingredients/materials and semi- and finished goods
  • Impact of methods of measurement and control on product and process quality and stability
  • The physical and chemical attributes of the product have implications in production

Attendance suggested for:

  • Years in industry: 0-4 to 5-14
  • Ideal audiences are those with 2+ years of industry experience that want to supplement their industry knowledge about a specific topic(s)
Mr. Charles F. Carney
Senior Affiliate Consultant
Seraphim Life Sciences Consulting

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).

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