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DIA 2021 Global Annual Meeting
Culture of Quality: A Competitive Advantage
- Principal Consultant
- Leslie Sam and Associates, 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.
Critical Thinking: The MUST HAVE When Elevating your Business Through Quality Culture
Michael Torok, PhD
- Senior Director, Clinical Quality Assurance
- Astellas, United States
Regulators Perspective on the Value of a High Performing Culture of Quality in Clinical Trial Research
- GCP Operations Manager and Lead Senior GCP Inspector
- Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom