DIA 2021 Global Annual Meeting

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Culture of Quality: A Competitive Advantage

Session Chair(s)

Leslie Sam

President

Leslie Sam and Associates, LLC, United States

ICH E8(R1) requires sponsors to “Create a culture that values and rewards critical thinking and open dialogue”. This session provides strategic and tactical approaches for optimizing an organization’s culture of quality and critical thinking approaches.

Learning Objective : Summarize the state of research and development culture of quality; Recognize culture of quality values, behaviors, traditions; Describe phases for optimizing culture of quality; Describe critical thinking and why it is important to a quality culture; Explain the critical thinking 4As framework; Describe a maturity model for developing critical thinking skills focused on drug development.

Speaker(s)

Critical Thinking: The MUST HAVE When Elevating your Business Through Quality Culture

Michael Torok, PhD

Genentech, A Member of the Roche Group, United States

Vice President, Global Head of Quality Assurance Programs

Regulators Perspective on the Value of a High Performing Culture of Quality in Clinical Trial Research

Jennifer Martin

Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

GCP Operations Manager and Lead Senior GCP Inspector

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