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Quality Metrics: The Carrot or the Stick?
Session Chair(s)
Sarah Pope Miksinski, PHD
Executive Director, CMC Regulatory Affairs, Gilead Sciences, United States
Subsequent to the recently-revised (November 2016) Quality Metrics draft guidance, industry and regulatory experts will address the benefits and challenges posed by the newly revised draft guidance for various segments of the pharmaceutical industry, proposed solutions, different approaches to metrics analysis and implementation, and the quality culture as part of the metrics equation.
Learning Objective : Discuss the advantages and disadvantages of the updated Quality Metrics draft guidance on the pharmaceutical industry
Speaker(s)
Steven Mendivil
Senior Advisor International Quality, Amgen Inc., United States
Industry Perspective
Michael G. Davidson
Vice President, Quality Systems and Compliance , Pfizer Inc., United States
Industry Perspective
Barbara Allen, PHD
, International Quality Expert, United States
Industry Perspective
Tara Gooen Bizjak, MS
Regulatory Officer, OC, CDER, FDA, United States
Panelist
Alex M. Viehmann
Operations Research Analyst, OS, OPQ, CDER, FDA, United States
Panelist
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