Connect Conference & Show Floor Educational Sessions

View, browse and sort the list of Connect Conference sessions and show floor programming by pass type, track, and format. Please note, all Connect Conference delegates have access to CPhI Connect and InformEx Connect programming. Seating is first come, first serve, so please arrive early to sessions that you would like to attend. Sessions are subject to change.

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  • USP <232> Elemental Impurities - Limit Chapter Requirements Update - Best Practices and Standardized Methods for Metals Testing - Powered by United States Pharmacopeia

    Speaker:
    Location:  118C
    Track: Regulatory Spotlight
    Pass Type: Connect Delegate, VIP Attendee, Exhibitor, Connect Delegate - Get your pass now!
    Vault Recording: TBD

    Driven by the International Conference on Harmonization (ICH) , Food and Drug Administration (FDA) guidances, consumer awareness and advancements in scientific detection and pharmaceutical manufacturing technologies, implementation of USP General Chapters <232> and <233> (Elemental Impurities - Procedures) to harmonize across USP, European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and ICH is in progress. Effective January 1, 2018, USP Heavy Metals 〈231〉 will be omitted and all references to it in general chapters and monographs will be deleted. The currently official USP <232> chapter goes into effect on January 1, 2018, will require new methods of sample preparation and analysis.This presentation will outline key changes, along with an insight into harmonization and implementation strategy.

    Topics will include:
    • An update on chapter <232> - Limits and the status of USP's harmonization with ICH-Q3D
    • Impact of <232> on other USP general chapters (element specific chapters) and how it will be addressed
    • Elemental impurities <232> implementation plans