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Tuesday, June 28 • 4:00pm - 5:00pm
#269: Making Quality Stick: Building a Complete Quality Culture

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Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

Interactive panel discussions and audience data gathering provides examples of cultural elements to further implementation and sustainment. The audience will leave with ideas to change the mindset from tone at the top to DNA of the broad enterprise. We will discuss the role of culture in quality management systems, how to build a quality culture, and a local non-pharma executive provides perspective on building a quality culture.

Learning Objectives

Discuss examples of successes and challenges in implementing quality management systems including how culture plays a role; Describe methods, tips, and approaches to managing detractors so that you can drive a culture of quality.

Chair

Coleen Glessner, MBA

Speaker

Panelist
Elizabeth Luczak, MBA

Panelist
William Andrew Erhardt, DrMed



Chair
avatar for Coleen Glessner

Coleen Glessner

Vice President, R&D Quality and Compliance, Alexion
As Vice President, Head of Research and Development Quality and Compliance at Alexion, Coleen leads the establishment of a quality management system for R&D to assure the highest standards of Quality in ultra-rare diseases. Most recently, she has been focused on implementing sustainable processes and controls for Alexion’s accelerated growth while developing a culture of quality. She has a BS from the University of Pittsburgh and an MBA from... Read More →

Speakers
WE

William Erhardt

Vice President, Global Product Development, Pfizer Inc
Bill is a board certified physician in Pediatrics and Pediatric Infectious Diseases and has completed a Staff Fellowship in Regulatory Sciences at the U.S. FDA. Bill joined Pfizer in 1999. Since joining the company Bill has served as a leader in both Clinical Development and Medical Affairs across several of Pfizer’s therapeutic areas. Currently, Bill serves as Vice President and Head of Clinical Operations within Global Product Development.
avatar for Elizabeth Luczak

Elizabeth Luczak

Vice President, Regulatory Compliance Quality Assurance, Covance Inc.
Elizabeth is Vice President of Regulatory Compliance/Quality Assurance at Covance (division of LabCorp) where she heads a global group of quality assurance professionals providing quality management strategies across clinical development services. | | Elizabeth has more than 25 years of experience in quality and compliance model design and implementation across GxP disciplines in both sponsor and CRO organizations, with focus on culture and... Read More →


Tuesday June 28, 2016 4:00pm - 5:00pm
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA