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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  • The World of Quality Metrics - Yesterday, Today and Tomorrow

    Speaker:
    • Marla Phillips  |  Former Head of Quality for Merck NC Facility, Xavier University
    Location:  113C
    Track: Regulatory / Quality
    Pass Type: Connect Delegate, VIP Attendee - Get your pass now!
    Vault Recording: TBD

    I. Why is there so much attention on metrics?
    How does the FDA want to use metrics and why?
    How does industry NOT want FDA to use metrics and why?
    What is driving the need for metrics for FDA and industry?

    II. What are the metrics FDA is considering?
    CDER's approach to metrics and what they are
    CDRH's approach to metrics and what they are
    Why is there a difference across CDER and CDRH?
    How can industry use the metrics to inform decision and trigger action?

    III. How to quantitate a commitment to quality
    The role of Culture in an organization's commitment to quality
    How to quantitate the commitment to quality
    How to improve the reliability of your product

    IV. Interactive Exercises
    Work with your colleagues to explore successful practices on metrics
    Table discussions to articulate cultural impact