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Monday, March 20 • 1:00pm - 4:00pm
Workshop C: The Ugly Truth: A Deep Dive into TMF Review

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Limited spots left, please check with our staff at the registration desk for availability

We all face it – do we do enough for quality review, how can it be better, and is it going to be sufficient for inspection readiness? We learn to not trust because no matter how many we perform, Auditors and Inspectors continue to find reasons for us to feel insecure about our quality review process.
In this session, we will discuss multiple scenarios for your starting point:
    • We have no quality review process implemented
    • We have a process, but it isn’t satisfactory
    • We want to improve a solid process
Understanding your tools, understanding your systems, and understanding your TMF Contents – creating your relationships for support and subject matter expertise and taking on only what your TMF group can take on but establishing a business case for other functions to participate are THE constant challenges to getting an effective and thorough Quality Review Process established.
Join us by bringing your experience, your questions, and your concerns about how to improve a quality review process in your organization.

Speakers
avatar for Jason King-Andreini

Jason King-Andreini

Associate Director, TMF Operations, BridgeBio Therapeutics
Jason is a Trial Master File enthusiast and lecturer – as well as TMF Operations Lead at BridgeBio Therapeutics. His job requires him to share the gift of TMF Purpose and Process with his teams across multiple affiliates and many projects, in addition to participation in multiple... Read More →


Monday March 20, 2023 1:00pm - 4:00pm EDT