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The presenters will provide an overview of the recently re-issued IPEC Significant Change Guide for Pharmaceutical Excipients. The primary goal of the guide is to establish a uniform approach to evaluate the significance of changes involving the manufacture and distribution of excipients. The guide was originally published in 2000, followed by revisions in 2005, 2009 and 2014.
Manager II, Operational Quality, Pharma Solutions
IFF
Ann’s background is in the field of materials science and engineering. She has been employed by The Dow Chemical Company for 31 years, first in the R&D Department and later in quality. She was first introduced to the concept of “good manufacturing practices” in 1999 and has worked with GMP products ever since. She has led 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 IFF as a business-level quality manager.
Ann joined IPEC-Americas in 2016 and is Chair of IPEC-Americas Excipient Qualification Committee.
R&D Senior Supervisor
Perrigo
Jennifer Putnam is a Senior Supervisor, Analytical R&D at Perrigo. She leads a team of scientists responsible for raw material characterization and evaluation in support of alternate source qualification and impact assessment of supplier changes for materials used in the products manufactured at Perrigo’s Michigan, USA sites, primarily solid and liquid oral generic drug products. Jennifer received a B.S. in Chemistry from Saginaw Valley State University. She is currently the Vice Chair of IPEC-Americas Compendial Review/Harmonization Committee.