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QUALITY TRACK: Panel - Drive a Quality Culture
Thursday September 26, 2024 2:15pm - 3:00pm EDT
Relate Risk-Based Quality Management (RBQM) Operational Improvements to Cultural Change and Fuel a Quality-First Organization  
  • Consider how using quality by design as a broader business objective and partnering across R&D demonstrates value of Quality to the organization 
  • Explore the shift in the RBQM era that affects the ways of working and innovating from analytics and AI to vendor oversight and management 
  • Manage the operational complexity of acquisitions happening across the industry impacting the processes, people, technologies, and external stakeholders 
  • Discuss the change management approaches used to navigate the emotional engagement and upskilling needed to bring people to the next level 

Moderators
avatar for Paul Houri

Paul Houri

Senior Vice President, Chief Quality Officer, Bristol Myers Squibb
Speakers
avatar for Sheri Kuss

Sheri Kuss

Sr. Director, GCP Quality Vaccines Category Head, Pfizer
A clinical research professional with over 20 years of GCP experience including FDA inspection preparation and facilitation, FDA Warning Letter remediation plan development, quality and compliance assessment, project management, auditing, process and SOP development, monitoring, training... Read More →
avatar for Jennifer Krohn, MS, CCRP

Jennifer Krohn, MS, CCRP

Associate Director, RBQM, Clinical Operations, Gilead Sciences
I have over 10 years of experience in leading and overseeing the centralized statistical monitoring and risk-based quality management (RBQM) of clinical trials. My mission is to ensure the quality, safety, and efficiency of clinical data and operations, and to support the delivery... Read More →
avatar for Grace Crawford

Grace Crawford

Head, Clinical Operations Quality & Learning, AstraZeneca
Grace is accountable for the development, implementation, maintenance and adoption of business quality management practices and GxP learning services for BioPharma Clinical Operations, and relevant areas within R&D BioPharmaceuticals and R&D Oncology. Grace has extensive experience... Read More →
Thursday September 26, 2024 2:15pm - 3:00pm EDT
  Clinical Quality Track
  • Qtag clinicalqualityfeaturedsession

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