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Session 4B: Impurities - Metal Impurities
Session Chair(s)
John F. Kauffman, PhD, MBA
Deputy Director
FDA Division of Pharmaceutical Analysis, United States
This session will provide a status update on the ICH Q3D guideline on metal impurities in pharmaceuticals and a description of the IPEC Q3D Information Exchange Request documents. In addition, examples of risk-based approaches to controls on metal impurities in pharmaceuticals will be described. At the conclusion of the presentations, the panel of speakers will be available to answer questions from the audience.
Speaker(s)
Approaches To Assess And Control Metal Impurities In Drug Products
Mark G. Schweitzer, PhD
Novartis Pharmaceuticals Corporation, United States
Global Head, Analytical Science and Technology
ICH Q3D Metal Impurities – Excipient Realities and Challenges
Katherine L. Ulman
Dow Corning, United States
Associate Scientist & Global Regulatory Compliance Manager
Metal Analysis in Pharmaceuticals: Impending Changes and Potential Strategies to Address Them
Nancy Lewen
Bristol-Myers Squibb, United States
Principal Scientist
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