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Thursday, June 23 • 10:00am - 11:00am
#409: How to Build and Support a Culture that Values Critical Thinking and Open, Proactive Dialogue About Quality

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-652-L04-P ; CME 1.00; RN 1.00

The newly adopted ICH E8(R1), section 3.3.1 encourages organizations to “create a culture that values and rewards critical thinking and open, proactive dialogue about what is critical to quality for a particular study or development program, going beyond sole reliance on tools and checklists.” This has generated many questions across the industry including: what is a culture of quality, how can organizations encourage and reward quality cultural behaviors, and how can organizations to measure and monitor quality culture? This session will explore how organizations are cultivating an environment that fosters critical thinkers, why quality culture should be an elemental attitude integrated in organizational structures and behaviors and how to measure, monitor and support desired quality culture behaviors.

Learning Objectives

Discuss the key components and success factors of a culture of quality; Describe three culture of quality enablers and how to apply them successfully to clinical development activities; Determine metrics for monitoring quality culture and how to analyze them and define action plans.


Linda Sullivan, MBA


Quality Culture: More than Just Behaivors
Dagmar Goertz

A High Performing Team Leverages Culture of Quality: Enablers to Design a Protocol Amendment - A Case Study
Michael Torok, PhD

Monitoring the Performance of a Quality Culture: A Case Study
Leslie Sam

avatar for Dagmar Goertz

Dagmar Goertz

Director Organizational Excellence, Janssen-Cilag GmbH, Germany
Dagmar holds the role of Director Organizational Excellence in BioResearch Quality & Compliance (BRQC) at Johnson & Johnson. She joined the healthcare industry in 1988 and gained several years of experience in pre-clinical/clinical research at Grünenthal. Before she joined Pfizer... Read More →
avatar for Linda Sullivan

Linda Sullivan

Senior Advisor, Metrics and Performance Management, WCG, United States
Ms. Sullivan serves as the Senior Advisor, Metrics & Performance Management at WCG. She is the Co-Founder & former Executive Director of the Metrics Champion Consortium (MCC), an industry association dedicated to leading the drug-development enterprise in the adoption and utilization... Read More →
avatar for Michael Torok

Michael Torok

Senior Director, Clinical Quality Assurance, Astellas, United States
Michael Torok, Ph.D. is a Senior Director in Clinical Quality Assurance at Astellas. He currently leads Astellas’ CQA Process Improvement, Operational Excellence, and Audit Center of Excellence groups. He is passionate about leveraging quality analytics to enhance risk and issue... Read More →

Thursday June 23, 2022 10:00am - 11:00am CDT
Room 185 AB McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616