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