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Moderators
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 units first-level online education, comprehensive instructor-led training, and practical case study workshops. Learn more at www.academy.cyntegrity.com
Johann Proeve (PhD)
Cyntegrity
CSO & Lead Instructor
Johann has over 45 years of experience as a biopharmaceutical industry expert, mainly in the former role of VP of Global Clinical Data Management at Bayer Healthcare. 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.
Keith Dorricott (MBB)
Cyntegrity
Lead Instructor
A Master Black Belt since 2007, Keith applies Lean Six Sigma to optimize clinical-trial workflows, reengineer processes, and drive performance metrics. A frequent speaker at SCOPE and the MCC Summit, he makes complex methodologies practical. He leads the mindsON RBQM Expert Working Group and facilitates Avoca Quality Consortium workstreams on Centralized Monitoring, eCOA, and Vendor Oversight.
Why do people still think 100% SDV is gold standard quality?
Many teams believe that the lowest risk to quality is 100% Source Data Verification (SDV) and 100% Source Data Review (SDR). And yet all the evidence points to the limited value of SDV, given the high level of resources needed and SDR being a tool to understand site processes. How can we help our industry colleagues move away from using 100% SDV and SDR as the default option? Come along to share your views via polling, whiteboards, or to listen and learn.
ABOUT "mindsON RBQM" WORKSHOPS
The mindsON RBQM workshops provide practical, system-agnostic guidance on the challenges of implementing and executing Risk-Based Quality Management (RBQM) in day-to-day clinical trial operations. These sessions emphasize interactive dialogue and problem-solving, offering a collaborative space to share experiences, explore strategies, and tackle real-world challenges.
Rooted in Quality by Design (QbD) principles, mindsON RBQM focuses on concepts and strategies that are not tied to any specific system. For those looking to see these principles applied through technology, the actON QbD series offers complementary workshops with live demonstrations of use cases powered by the MyRBQM Portal.
Whether you choose to participate or simply observe actively, mindsON RBQM provides the knowledge and tools you need to navigate RBQM implementation confidently and effectively.
More about the mindsON Expert Working Group: https://www.minds-on.org/
Join our group on LinkedIn: https://www.linkedin.com/groups/10088435/
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