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This webinar will review the recently re-issued IPEC Excipient Information Package User Guide and Templates. This guide is designed to facilitate the excipient supplier's sharing of information with the user in a standardized way. The guide and templates were first published in 2005 then subsequently revised in 2009, 2013 and 2020. An overview of the guide/template and major revisions will be provided.
In addition, presenters will review IPEC-Americas thoughts and position on "Data Integrity for Pharmaceutical Grade Excipients" as well as "Selecting Appropriate Excipient GMPs".
The revised Excipient Composition Guide will also be discussed. The guide was originally published in 2009 and is now being revised to update the references contained therein and has been converted into an IPEC Federation guide, representing inputs from all IPEC members, namely the Americas, China, Europe, India and Japan.
- Overview of the IPEC EIP User Guide and Templates, including recent major changes
- IPEC’s position on the relevance of data integrity guidance documents to the manufacture and supply of excipients
- Understanding for data integrity concepts explicitly included in excipient GMP standards and guides
- Excipient data integrity recommendations for excipient manufactures and users
- Explanation for multiple excipient GMP documents available and how they may be used
- Ability to make an informed decision regarding which excipient GMP document to adopt
Dale graduated with a BS in Chemistry from Davidson College in 1983 and an MS in Chemistry from North Carolina State University in 1988. From 2000 he spent 8 years as Manager, Product Quality & Management Systems at the Archer Daniels Midland Company in global food processing and commodities trading. From 2008 – August 2017, Dale was Global Director of Quality at the JM Huber Engineer Materials Silica Business Unit. Following the Huber acquisition by Evonik Industries on 1st September, 2017 he became Head of Quality BL Silica NAFTA responsible for the North America region where Evonik has a combination of 6 Silica plants.
Dale represented JM Huber as a member of the IPEC-Americas. He was a member of the GMP Committee from 2001 – 2010 and as Chairman from 2011-2013, During this time, he was a member of the EXCiPACT project team and he became a Board Director of EXCiPACT asbl in February 2017 representing IPEC-Americas.
Bretta Lichtenhan is Head of Pharma Registrations within Pharma Food Materials organization of the Life Science division of MilliporeSigma. She manages a global team of regulatory experts, focused on regulatory registration of products such as active pharmaceutical ingredients (APIs), highly potent APIs, linkers, antibody-drug conjugates, excipients, and pharmaceutical materials for the (bio-) pharmaceutical industry. Bretta also currently serves as Chair-Elect of IPEC-Americas, an industry association focused on advocating, educating, innovating and developing best practices for excipients, with a focus on patient safety. She has over 22 years of experience in the industry with previous experience at Biopharma companies Genzyme (a Sanofi Company) and Percivia LLC. Bretta has worked for MilliporeSigma for over 10 years in various roles from R&D Product Development, Product Management, Business Development and Regulatory Affairs. Bretta has a bachelor’s degree in Biology from the University of New Hampshire and Master’s of Biotechnology Engineering from Tufts University in the United States.
Ann’s background is in the field of Materials Science and Engineering. She spent 31 years working for The Dow Chemical Company, first in the R&D Department and later in the Quality function. She was first introduced to the concept of “good manufacturing practices” in 1999 and has worked with GMP products ever since. She has lead implementation of API, excipient and cosmetic ingredient GMP at multiple sites, and represented quality assurance for products sold as active ingredients, excipients, cosmetic ingredients, food additives and food contact materials.
Ann is currently working for DuPont Nutrition & Health as a business-level quality manager.
Ann joined IPEC-Americas in 2016 and is committee chair for the Excipient Qualification committee.