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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.


Danae   Christodoulou

Elemental Impurities: FDA Perspective

Danae Christodoulou

  • Acting Branch Chief, Office of Pharmaceutical Quality, ONDP, CDER
  • FDA, United States
Kahkashan  Zaidi, PhD

USP Elemental Impurities: An Update

Kahkashan Zaidi, PhD

  • Principal Scientific Liaison
  • USP, United States
Melissa  Figgins

Industry Perspective on Elemental Impurity Standards and Guidelines

Melissa Figgins

  • Head Project Management
  • Novartis Services Inc, United States

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