mindsON RBQM | Special Edition - Audit Trails exposed: Why they matter for RBQM
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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
GUEST SPEAKER:
Nechama Katan
Nechama Katan is a Wicked Problem Wizard who helps organizations define, drive, and deliver projects focused on Risk-Based Quality Management (RBQM), audit trail analytics, and data quality projects in clinical trials.
With deep expertise in data science, analytics, and trial operations, she spent over eight years building and leading an RBQM team within Pfizer where she also pioneered efforts to integrate audit trail analytics into risk-based workflows.
Nechama holds an M.S. in Mathematics from the Courant Institute at NYU and an M.S. in Statistics from Columbia University.
Keith Dorricott, MBB
Lead Instructor
MyRBQM Academy
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.
Dr. Johann Proeve
Chief Scientific Officer
Cyntegrity
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.
Why Attend?
Every keystroke in an EDC or CTMS leaves a digital breadcrumb. String those crumbs together and you see the story of your study:
• Who entered or changed the data, and when
• Which sites rush to edit at month-end
• Where protocol drift starts to surface
In this mindsON RBQM | Special Edition – “Audit Trails Exposed: Why They Matter for RBQM,” we shift the focus from what was captured to how it was captured, showing why the process view is a stronger early-warning system than static data checks alone.
Join guest speaker Nechama Katan, Dr Johann Proeve, and Keith Dorricott to explore:
>> Audit-trail patterns that flag emerging risk weeks sooner
>> Practical KPIs for continuous RBQM dashboards
>> Tips for mining trails without drowning in noise
Expect live polls, interactive whiteboards, and a lively Q&A. Listen, vote, or jump on the mic—the floor is yours!
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 without being 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.