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What is expected in filings to demonstrate elemental impurity compliance for drug products? What type of information is expected from suppliers? What is industry hearing from FDA after review of the filing information submitted? This webinar will also clarify ICH Q3D requirements in light of recent FDA feedback from these reviews.
- Understand ICH Q3D requirements for suppliers and drug product manufacturers.
- Gain a perspective on how FDA is responding to information submitted.
- Learn about IPEC-Americas efforts to engage FDA to address misunderstandings related to implementation of elemental impurity reporting.
Priscilla Zawislak – Vice President, IPEC Federation, Immediate Past-Chair, IPEC-Americas
Priscilla has over 35 years’ experience in Regulatory Affairs and Quality for excipients, food additives and ingredients for personal care products. Currently with IFF (International Flavors & Fragrances, formerly DuPont Nutrition & Biosciences), she is the Global Regulatory Affairs Advocacy Manager for the pharmaceutical business and is responsible for regulatory advocacy for excipients, APIs and food additives. Prior positions included Global Regulatory Affairs Manager for Ashland Specialty Ingredients Pharmaceutical and Nutrition business where she was responsible for regulatory compliance for food additive and excipient products, and Quality Manager at FMC Health and Nutrition (which is now part of IFF).
Priscilla is currently Vice-President of the IPEC Federation, a global organization consisting of regional IPECs in the US, Europe, China, Japan and India. She is also the Immediate Past Chair of IPEC-Americas, has been an active member of IPEC-Americas committees since 2001, is a member of the IPEC Americas Executive Committee and a member of the Board of Directors of EXCiPACT®. She has been a member of several USP project teams and is a delegate to the USP Convention.
Priscilla earned her degrees in Biological Sciences and Chemistry from the University of Delaware.