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A Holistic Approach to Achieve Fit for Purpose Clinical Trial: Integrating a Function-Agnostic End-to-End Quality by Design and Risk-Based Quality Management Strategy
Session Chair(s)
Paula Walker, MA
Global Head of Risk Based Quality Management
Roche, United Kingdom
This session will provide a practical, high-level walk-through of how Quality by Design (QbD) and Risk-Based Quality Management (RBQM) Strategy work synergistically, centered on Critical to Quality (CtQ) factors, demonstrating how to build a unified quality strategy that aligns with regulatory expectations.
Learning Objective : Define and identify CtQ factors using integrated QbD and RBQM in a collaborative, cross-functional setting; Demonstrate the synergistic application of QbD and RBQM across the clinical trial lifecycle; Discuss regulatory expectations and industry best practices for a unified quality strategy; Provide practical strategies for implementing this approach within organizations.
Speaker(s)
Panelist
Paula Walker, MA
Roche, United Kingdom
Global Head of Risk Based Quality Management
Panelist
Representative Invited
Health Sciences Authority, Singapore
Panelist
Representative Invited
FDA, United States
Panelist
Representative Invited
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
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