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Wednesday, June 26 • 8:00am - 9:15am
#315: Measuring and Assessing Product Manufacturing Quality

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-662-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

Describe different methodologies to assessing product and manufacturing quality; Discuss the role of FDA’s Office of Pharmaceutical Quality (i.e., Office of Surveillance) in determining risks associated with manufacturing facilities and products; Identify the vision of how FDA programs can enhance risk-based regulatory oversight of manufacturing quality.


Giuseppe Randazzo, MS


How FDA’s Office of Pharmaceutical Quality Applies Quality Surveillance to Assure Drug Quality
Karthik Iyer, MS

Erin Fox, PharmD

Industry Perspective
Cylia Chen, MS


Cylia Chen

Director of Quality, Amgen
Cylia leads development of external engagement strategies for Amgen and is actively engaged with several industry associations such as PhRMA, BIO, PDA, RX-360, ISPE, and others. She is currently the co-leader of PDA Quality Metrics/Culture Task Force Team and have led a panel of experts... Read More →
avatar for Erin Fox

Erin Fox

Senior Director, Drug Information and Support Service, University of Utah Health
Erin directs the University of Utah Health Care Drug Information Service (UUDIS) and is adjunct associate professor at the UU College of Pharmacy. The UUDIS provides drug shortage content for the American Society of Health-System Pharmacists. Erin is recognized as an expert in drug... Read More →
avatar for Karthik Iyer

Karthik Iyer

Associate Director, CDER, FDA
Karthik is currently an associate director for Data and Analysis in the Office of Surveillance. Prior agency roles included CMC reviewer (Office of Process and Facilities), Acting Branch Chief ( Office of Surveillance) and Senior Policy Advisor (Office of Manufacturing and Product... Read More →
avatar for Giuseppe Randazzo

Giuseppe Randazzo

Director, Office of New Drug Products, OPQ, CDER, FDA
Giuseppe serves as Director of the Office of New Drug Products (ONDP) in CDER at FDA. ONDP is responsible for conducting risk and team-based, quality assessments of INDs, NDAs, and active pharmaceutical ingredient (API) information supporting NDAs and ANDAs. Giuseppe has been at the... Read More →

Wednesday June 26, 2019 8:00am - 9:15am
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA