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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
With 45+ years in biopharma, including 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 drive 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
- July 7, 2026, 3:00 PM - 4:00 PM
How CTQs Underpin Risk-Proportionate Oversight
Quality by Design (QbD) is often discussed as a principle, but its value depends on how well it shapes real trial decisions.
In this session, we will explore how QbD fits within RBQM under ICH E6(R3), and why Critical to Quality factors (CTQs) should influence study design, risk assessment, monitoring strategy, and oversight planning from the start.
We will discuss what can go wrong when CTQs are unclear, why not every risk deserves the same level of control, and how teams can focus on what matters most for patient safety, data reliability, and inspection readiness.
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 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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