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Wednesday, June 19 • 2:30pm - 3:00pm
#358 CH: RBQM (Risk-Based Quality Management): What Topics Should be Discussed with Whom in the Room?

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Component Type: Workshop
Level: Intermediate

Critical-to-Quality (CtQ) factors are key to determining which protocol-related processes and variables matter. These should be defined cross-functionally during risk assessment and built into all functional plans to have a common focus and approach.

Learning Objectives

Define Critical-to-Quality (CtQ) variables; Streamline CtQ to all functional plans for common approach; Understand the benefits from reduced SDR/SDV by focusing on CtQ as variables that matter.

Chair

Terry Katz, MS

Speakers
avatar for Terry Katz

Terry Katz

Senior Director, Biostatistics and DM Planning and Functional Excellence, Daiichi Sankyo, United States
Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician... Read More →

Wednesday June 19, 2024 2:30pm - 3:00pm PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  15: Content Hubs, Workshop |   02: ClinTrials -ClinOps, Workshop