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.

To learn more about the Connect Conference program, click here.

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  • Drug Manufacturing: Quality Risk Assessment Management and Supply Chain Sourcing Strategies for APIs and Excipients - Powered by United States Pharmacopeia

    Speaker:
    Location:  112AB
    Track: Drug Manufacturing
    Pass Type: Connect Delegate, VIP Attendee - Get your pass now!
    Vault Recording: TBD

    Pharmaceutical companies are required by FDA to control the supply chain for all of the ingredients used in their products. Often, this translates into pharmaceutical companies conducting numerous and redundant GMP audits of their suppliers. Recently, several third-party GMP certification programs have introduced business models designed to help reduce the number and frequency of these audits. New proposals and guidelines suggest a dedicated risk assessment strategy can further help to improve efficiencies in resources and activities. This is an approach currently employed by FDA to determine the audit frequency and urgency in many regulated industries.

    This presentation will provide an overview of the advantages of different Certification business models, including the USP Verification program and how inclusion of Quality risk assessment management strategies can be used to help focus resources to the most critical ingredients in the supply chain.