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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 – IPEC-Americas Immediate Past-Chair; Vice President, IPEC Federation; Global Regulatory Affairs Advocacy Manager for Dupont Nutrition and Biosciences.
Ms. Zawislak Priscilla has over 35 years’ experience in regulatory affairs and quality for excipients, food additives and ingredients for personal care products. She is IPEC-Americas Immediate Past-Chair and is the current Vice President of the IPEC Federation. Priscilla is the Global Regulatory Affairs Advocacy Manager for Dupont’s pharmaceutical and nutrition business. Her responsibilities include regulatory advocacy for excipients, APIs and food additives. Prior positions include Global Regulatory Affairs Manager for Ashland Inc.’s Pharmaceutical and Nutrition business where she was responsible for regulatory compliance for food additive and excipient products and Quality Manager at FMC BioPolymer (now DuPont Health & Nutrition).
Ms. Zawislak is the Immediate Past Chair of IPEC-Americas, has been a member of IPEC-Americas committees since 2001 and is a member of the Executive Committee. She is also Vice President of the IPEC Federation, a global organization consisting of regional IPECs in the US, Europe, Japan, China and India. She is an IPEC-Americas representative on several USP related committees including the Excipients Project Team, Compendial Process Improvement Team, General Notices Project Team, has served as Chair for several Stakeholder Forums, and is a Delegate to the USP Convention. Priscilla has also participated for over 10 years in the International Food Additives Council and OFCA, a trade association for cellulose derivatives. Priscilla earned her Bachelor degrees in Biological Sciences and Chemistry from the University of Delaware.