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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Subsequent to the recently-revised (November 2016) Quality Metrics draft guidance, industry and regulatory experts will address the benefits and challenges posed by the newly revised draft guidance for various segments of the pharmaceutical industry, proposed solutions, different approaches to metrics analysis and implementation, and the quality culture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Learning Objective : Discuss the advantages and disadvantages of the updated Quality Metrics draft guidance on the pharmaceutical industry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)
Industry Perspective
Senior Advisor International Quality, Amgen Inc., United States
Industry Perspective
Vice President, Quality Systems and Compliance , Pfizer Inc., United States
Industry Perspective
, International Quality Expert, United States
Panelist
Regulatory Officer, OC, CDER, FDA, United States
Panelist
Operations Research Analyst, OS, OPQ, CDER, FDA, United States
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