Expectations for Developing and Sharing Excipient Composition Information

Description

This webinar is intended to provide attendees with an understanding of the fundamental sources and types of components that might be present in an excipient. It will also offer best practices for characterizing an excipient composition profile and discuss potential analytical variabilities and limitations.

In addition, presenters will suggest best practices for excipient manufacturers to communicate composition information with users and regulators while avoiding potential pitfalls.

Contributors

Dave R. Schoneker

President/Owner
Black Diamond Regulatory Consulting, LLC

David R. Schoneker is currently the President/Owner of Black Diamond Regulatory Consulting, LLC, a consulting firm specializing in providing regulatory and quality consulting for the pharmaceutical, dietary supplement, food and related industries. The firm provides expert advice for difficult problems and training on excipient and food additive regulatory, quality and supply chain concerns.

He is a past Chair of IPEC-Americas, received the IPEC Foundation Louis Blecher Lifetime Achievement Award in the field of excipients in 2018, and is currently Chair of QbD/Composition Committee – IPEC-Americas and an Executive Committee Emeritus Member.
Paul Smutz

Global Compliance Manager
Henkel Corporation

Paul Smutz is the Global Compliance Manager for Henkel Corporation’s Drug Delivery Polymers group. With a 29-year background in chemistry, technical service, quality, product development, qualification, regulatory and GMP compliance, Paul leads the Product Integrity Group with responsibilities for DMFs, audits, stability studies, component profiles, specifications, product reviews and excipient GMP compliance amongst others.

Paul has been a member of IPEC-Americas since 2001. He is the past chair for the IPEC-Americas GMP Committee and current Vice Chair for Makers and Distributors on the IPEC-Americas Executive Committee. He has contributed to various guides, position papers, and infographics as well as volunteered and supported various committee projects.
Elizabeth Febbo

Global Laboratory and Project Manager
Henkel Corporation

Elizabeth Febbo has a background in chemistry and quality control. She has spent over 23 years with Henkel Corporation (previously National Starch and Chemical). In the early years Beth supported the industrial adhesives group prior to joining the Drug Delivery Polymer group. Over her career, Beth has held positions in the lab, development and quality. Her current role within Henkel involves managing the Drug Delivery laboratory. She oversees several initiatives which include method development, stability studies, component composition studies, process and product qualification activities and quality Control support.

Beth has been involved with IPEC-Americas since 2012. She is the current vice chair of the GMP committee and has participated in/supported various volunteer activities.
Joseph Zeleznik

Technical Director
North America at IMCD

Joseph Zeleznik is Technical Director, North America for IMCD US and is also a member of IPEC-Americas’ Executive Committee, and Chair-elect for the 2024-2025 term. In addition to training activities, he provides customer seminars and advises with customer product & process development as well as working closely with IMCD’s many principals. Prior to joining IMCD US, Joe served as Manager, Technical and Regulatory Affairs with MEGGLE USA, Inc. and Associate Director, R&D with JRS PHARMA.

Joe holds B.S. and M.A. degrees in Chemistry from the State University of New York, College at New Paltz. He has contributed to articles published across various industry journals as well as the Handbook of Pharmaceutical Excipients, 8th Ed. He helped development the NF co-processed excipient monograph, Silicified Microcrystalline Cellulose.

Description

Contributors

Dave R. Schoneker

Paul Smutz

Elizabeth Febbo

Joseph Zeleznik