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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
Chief Scientific Officer
With 45+ years in biopharma, including serving as VP, Global Clinical Data Management at Bayer, Johann brings data-driven realism to make strategies executable. A sought-after industry speaker, he translates complex clinical research practices into workable models. He is a member of the mindsON RBQM Expert Working Group, contributing seasoned sponsor-side experience to its oversight deliverables.
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 improve performance metrics. A frequent speaker at SCOPE and the MCC Summit, he makes complex methodologies practical. Keith leads the mindsON RBQM Expert Working Group.
Appointments
- October 20, 2026, 3:00 PM - 4:00 PM
Avoiding Unnecessary CAPA: How Risk-Proportionate Thinking Reduces Fire-Fighting
Issues are inevitable in clinical trials — but many significant issues can be prevented, reduced, or detected earlier when risk management and issue management are properly connected.
In this session, we will explore how QbD and RBQM can help teams move from reactive issue handling to proactive issue prevention. The focus will be on how assessing likelihood, impact, and detectability can be used to prioritize and then control risks. To reduce the chance that issues occur in the first place — and to detect emerging problems before they become serious quality events.
We will discuss how effective risk management can reduce firefighting, avoid unnecessary CAPA, and help teams focus their effort where they add the most value. We will also look at how issue management should not sit separately from risk management but rather feed into a continuous oversight model in which risks, controls, signals, and actions remain connected.
This session will be particularly relevant to QA, clinical operations, vendor oversight, monitoring, centralized monitoring, and inspection-readiness teams.
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 system-agnostic concepts and strategies. 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 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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