The presentation will focus on:
> Fundamental principles for managing changes related to excipient manufacturing and supply
> The role of risk assessment in evaluating change
> Excipient manufacturer (maker) best practices and case studies for evaluating changes for level of significance
> Finished drug manufacturer (user) best practices and case studies for managing significant changes
Manager II, Operational Quality, Pharma Solutions
IFF
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 quality. 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 IFF as a business-level quality manager. Ann joined IPEC-Americas in 2016 and is the Excipient Qualification Committee Chair.
Analytical 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 IPEC-Americas Vice Chair of the Compendial Review/Harmonization committee.
Global Regulatory Affairs Advocacy Manager
IFF
Priscilla Zawislak has over 35 years’ experience in regulatory affairs and quality for excipients, food additives and ingredients for personal care products. She is a past Chair of IPEC-Americas and is the current President of the IPEC Federation. Priscilla is the Global Regulatory Affairs Advocacy Manager for IFF.