Elemental Impurities: Filing experiences - What is Industry Hearing from FDA?

Wednesday, August 21, 2019 - 11:00am

This is a webcast from a previously recorded webinar (August 21, 2019)

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.

Learning Objectives

Attendees will:

  • 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.

Presenter(s)

Priscilla Zawislak

Global Regulatory Affairs Advocacy Manager
Dupont Nutrition and Biosciences

Priscilla Zawislak – IPEC-Americas Immediate Past-Chair; 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 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 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.

Cancellation Policy

Note:

Cancellations for live webinars must be made in writing and can be mailed or e-mailed to:

IPEC-Americas Webinars
3138 10th Street N
Arlington, VA 22201
Suite 500
E-mail: ipecamer@ipecamericas.org

Registration fees are refundable for attendees registered for individual webinars, if cancellation is received at least five (5) business days prior to the course. Notices of cancellation received 0-4 business days prior to the course will not be provided a refund. If you registered and are unable to attend the webinar, a recording of the webinar will be provided.

No cancellations are available for webcasts (archived recorded webinars). Recordings are available for 21 days after purchase.

Questions?
Please contact IPEC-Americas Training Coordinator
571-814-3450 or email ipecamer@ipecamericas.org