The session will have two presentations
"A Rational Approach to Formulation Design" by R. Christian Moreton, B.Pharm., M.Sc., Ph.D. Partner, FinnBrit Consulting, Waltham, MA
This presentation will focus on pharmaceutical formulation and process design and development and how we select the excipients to be used in a rational and scientifically justified manner. The presentation will show how we can use the results of preformulation assessments, particularly in the selection of the excipients, to give the project the best chance of success. A straightforward 7-step approach to pharmaceutical formulation and process design and development will be discussed.
"Excipient and Supplier Qualification for High Quality Formulations" by David R. Schoneker President/Owner of Black Diamond Regulatory Consulting, LLC.
Excipients are selected during the formulation design and development stage when developing a drug product. This presentation will discuss effective excipient and supplier qualification considerations and what IPEC has done to develop appropriate guidance to assist the industry in developing robust formulations that meet or exceed patient needs.
Dr. Moreton has been a partner at FinnBrit Consulting since 2007. Prior to FinnBrit Consulting, he spent 30 years working in industry; mainly as a pharmaceutical formulation scientist working in large and small innovator companies, and in generic companies. He is a past Chair of IPEC-Americas and is currently a member of the IPEC-Americas QbD and Excipient Composition Committee and GMP Committee. Dr. Moreton is also a visiting lecturer/tutor at the Manchester University (UK).

David R. Schoneker is currently the President/Owner of Black Diamond Regulatory Consulting, LLC. He is an Adjunct Prof. at Temple University's School of Pharmacy in their RA/QA Master's Program. Prior to this he was Global Regulatory Director with Colorcon Inc. He is past chair of IPEC Americas and currently a member of the EC and Vice Chair for Regulatory Policy.

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