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Hyatt Regency Bethesda

Apr 13, 2015 7:00 AM - Apr 15, 2015 12:00 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

CMC Workshop 2015

Session 3A: Elemental Impurities

Session Chair(s)

John F. Kauffman, PhD, MBA

John F. Kauffman, PhD, MBA

Deputy Director

FDA Division of Pharmaceutical Analysis, United States

This session will address implementation of recently developed standards and guidelines for control of elemental impurities in drug products. Topics will include implementation of ICH Q3D: Guideline on Elemental Impurities and an update on USP chapters <232> and <233>. An industry perspective on the standards and guidelines will also be presented. At the conclusion of the presentations, the panel of speakers will be available to answer questions from the audience.

Speaker(s)

Danae   Christodoulou

Elemental Impurities: FDA Perspective

Danae Christodoulou

FDA, United States

Acting Branch Chief, Office of Pharmaceutical Quality, ONDP, CDER

Kahkashan  Zaidi, PhD

USP Elemental Impurities: An Update

Kahkashan Zaidi, PhD

USP, United States

Principal Scientific Liaison

Melissa  Figgins

Industry Perspective on Elemental Impurity Standards and Guidelines

Melissa Figgins

Novartis Services Inc, United States

Head Project Management

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