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Session 3A: Elemental Impurities
Session Chair(s)
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)
Elemental Impurities: FDA Perspective
Danae Christodoulou
FDA, United States
Acting Branch Chief, Office of Pharmaceutical Quality, ONDP, CDER
USP Elemental Impurities: An Update
Kahkashan Zaidi, PhD
USP, United States
Principal Scientific Liaison
Industry Perspective on Elemental Impurity Standards and Guidelines
Melissa Figgins
Novartis Services Inc, United States
Head Project Management
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