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Measuring and Assessing Product Manufacturing Quality
Session Chair(s)
Giuseppe Randazzo, MS
Vice President, Sciences and Regulatory Affairs
Association for Accessible Medicines, United States
Quality in pharmaceutical manufacturing is essential for patients but difficult to define and measure. This session will explore qualitative and quantitative approaches to assess the ability of manufacturers to make high quality medicines. Methodologies from FDA and Industry to measuring product and manufacturing quality will be discussed such as quality metrics and the New Inspection Protocol Project (NIPP).
Learning Objective : After listening to this forum, participants will be able to: • Describe the vision of the CDER/OPQ/Office of Surveillance • Discuss the several surveillance tools that are used to assure product quality for consumers • Recognize how data analytics supports improved surveillance decision making
Speaker(s)
How FDA’s Office of Pharmaceutical Quality Applies Quality Surveillance to Assure Drug Quality
Karthik Iyer, MS
Merck & Co., Inc., United States
Director, Global Quality
Panelist
Erin Fox, PharmD
University of Utah Health Care, United States
Senior Pharmacy Director
Industry Perspective
Cylia Chen, MS
Amgen, United States
Director of Quality
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