×
Don't Miss Out!
Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA!
Back to Agenda
Innovation at the Intersection: Clinical Operations, Data Management, and Quality Assurance on Quality-by-Design and Risk-Based Quality Management
Session Chair(s)
Michael Torok, PhD
Vice President, Global Head of Quality Assurance Programs
Genentech, A Member of the Roche Group, United States
This forum will present: Health Authority (HA) expectations related to QbD, RBQM, and issue management. Specific examples of how study teams use technology to overcome challenges in achieving QbD and effective RBQM and issue management practices.
Learning Objective : Understand Health Authority (HA) expectations when designing and executing clinical studies, specifically for using risk proportionate approaches in Quality by Design (QbD), Risk Based Quality Management (RBQM) and issue management practices; Describe real life examples of technologies that facilitate the achievement of HA expectations for QbD, RBQM, and issue management.
Speaker(s)
Industry Perspective
Michael Torok, PhD
Genentech, A Member of the Roche Group, United States
Vice President, Global Head of Quality Assurance Programs
FDA Perspective
Representative Invited
FDA, United States
Industry Perspective
Kevin Richards
AstraZeneca, Canada
Head Quality Investigations & Analytics
Have an account?