mindsON RBQM | Episode 7 - Linking Risks & Issues

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Moderators

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MyRBQM Academy by Cyntegrity

Targeted education helps clinical research teams embrace the implementation process and contribute to its success ensuring your organization’s RBQM strategy has the components it needs to meet regulatory expectations.

Established in 2019, Cyntegrity’s MyRBQM® Academy, unites first-level online education, comprehensive instructor-led training and practical case study workshops. Learn more at: www.cyntegrity.com

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Dr. Johann Proeve

Johann Proeve has over 35 years of experience as a biopharmaceutical industry expert, mainly in the former international role of Head of Global Data Management at Bayer AG. Besides being a much sought-after industry speaker, he brings data-driven realism to the table, ensuring that goals are implementable in the real world. Johann has a vast depth of experience in clinical research, which has been invaluable to many.

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Keith Dorricott, MBB

Keith has been a qualified Lean Six Sigma Master Black Belt since 2007. He has a solid background in the practical use of process improvement, business process re-engineering, and metrics in clinical trials. Having a wealth of experience across processes in clinical trials and being a frequent speaker at conferences such as SCOPE and the MCC Summit, Keith helps make the complex understandable. In his spare time, he also facilitates and provides thought leadership for workgroups at the MCC, such as Centralized Monitoring, eCOA, and Vendor Oversight.

July 1, 2021 William Clay

This was a great way to refresh the concepts from the My RBQM Green & Black Belt courses. Also, a good discussion of external factors that influence the data.

January 21, 2022 Jan Van Parijs

Great illustration of an extremely useful concept, with well-chosen practical examples that supplement and demonstrate the speaker's vast experience in clinical research and in applying RBM in practice. Combined with excellent "training" and explanation of "value added" process developed for MyRBQM.

April 6, 2022 Stacey Dudkowski

This was the first Webinar I have attended with you, but have registered for others. The content, dialogue, interactions and feedback were excellent.

Description

Section 5.20.1 of ICH E6(R2) refers to root cause analysis for significant noncompliances in clinical trials. This should lead to corrective and preventive actions. Does this relate at all to section 5.0 on Risk-Based Quality Management? After all, isn’t a risk a potential issue? And where an issue has occurred, the actions taken to reduce the likelihood or impact of recurrence are risk controls, aren’t they? Can you use historical data on issues to help with risk evaluation and control? Join us at this live workshop as our two experts provide their perspectives on these questions and, if you’d like, take the opportunity to ask your questions, brainstorm examples, and join the discussion.

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About "mindsON RBQM" workshops: mindsON RBQM is a series of workshops that provides practical advice on the challenging aspects of an RBQM roll-out and its daily execution. Each workshop allows room for interactive dialog and problem-solving exercises. We invite you to share your own experiences and participate in the interactive dialog. If you prefer to listen and observe, that's okay as well.

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