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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)
Michael Torok, PhD
Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States
Critical Thinking: The MUST HAVE When Elevating your Business Through Quality Culture
Jennifer Martin
GCP Operations Manager and Lead Senior GCP Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Regulators Perspective on the Value of a High Performing Culture of Quality in Clinical Trial Research
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