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Monday, June 28 • 4:00pm - 5:00pm
#149 SL: Culture of Quality: A Competitive Advantage

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-553-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Leslie Sam

Speaker

Critical Thinking: The MUST HAVE When Elevating your Business Through Quality Culture
Michael Torok, PhD

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



Speakers
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. His current work interests include using statistical processes to derive holistic... Read More →
avatar for Leslie Sam

Leslie Sam

President, Leslie Sam and Associates, United States
With 25 years+ of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by... Read More →
avatar for Jennifer Martin

Jennifer Martin

GCP Operations Manager and Lead Senior GCP Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Jennifer has a BSc in Chemistry. Prior to joining the MHRA in 2006 as a Good Clinical Practice (GCP) Inspector, she spent 13 years in the Pharmaceutical industry in pre-clinical working to Good Laboratory Practice (GLP) then moving to Clinical Research as a Clinical Research Associate... Read More →


Monday June 28, 2021 4:00pm - 5:00pm EDT
TBD Virtual Event Horsham, PA 19044
  08: RD Quality-Compliance, Session