Event Registration (EVENT: 442873

Screening Methods for Elemental Impurities: Proposed Compendial Requirements
Event Date: June 14, 2012 at 11:00 AM EDT for North America and on June 21, 2012 at 11:00 AM CET for Europe
The revised US Pharmacopeia revised chapters on elemental impurity limits and procedures (<232> and <233>) are to be published as final in June 2012 and will become official by the end of the year. Conformance to the standards will be required starting May 1, 2014, and companies are already beginning to make changes for implementation. At the same time, the International Conference on Harmonization (ICH) working group on elemental impurities, ICH Q3D, is continuing to develop a harmonized approach for controlling these impurities, including risk-assessment recommendations and safety limits for specific metals, that meet testing and regulatory filing requirements at the global level. This webinar will focus on the quantitative screening methods and procedures for detecting elemental impurities based on the new USP chapter (ICP-based tests versus qualitative colorimetric tests). Instrumentation, key challenges, best practices, and will be addressed.
Moderator: Angie Drakulich Editorial Director Pharmaceutical Technology / Pharmaceutical Technology Europe/ BioPharm International Speaker: Thomas Devadder Senior Analyst SGS Life Science Services, Germany Kahkashan Zaidi PhD Senior Scientist US Pharmacopeia Nancy Lewen US Pharmacopeia Elemental Impurities Advisory Panel Member, and Principal Scientist Bristol-Myers Squibb
IMPORTANT - PLEASE READ This is a FREE streaming audio Webcast and does not require a phone line. If you have any questions regarding this Webcast, please contact Jamie Carpenter, jcarpenter@advanstar.com. Register for this FREE Webcast!
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