Webinar - Review of USP 1663 Requirements - Extractable and Leachable Identification

Expert Speaker: Louis Fleck, Laboratory Manager, Trace Organic Analysis Group
USP <1663> provides detailed definitions for identification categories, including tentative, confident and confirmed.  Each level of identification requires a particular set of supporting evidence and consequently a particular level of effort.  This presentation will review the identification categories, provide context where tentative identification can be acceptable and discuss risks of incorrect or incomplete (tentative) identification. 

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Louis Fleck

Laboratory Manager, Trace Organic Analysis Group, Intertek Pharmaceutical Services

Louis Fleck is the Trace Organic Analysis Manager at Intertek Pharmaceutical Services in Whitehouse, NJ. He has 20+ years of experience performing and managing activities that directly support the pharmaceutical industry, including chromatographic method development and validation, and extractable and leachable testing.