Patricia F. Hughes, PhD

Senior Scientific Advisor, CDER
U.S. FDA

Patricia F. Hughes received a Ph.D. in Microbiology from Georgetown University and in 2020 year assumed the role of Sr. Scientific Advisor in the Office of Pharmaceutical Manufacturing Assessment (OPMA), Office of Product Quality in CDER/FDA. She is currently involved in developing and implementing policies for quality assessments of applications from a microbiology quality perspective and for the inspection program for biological products. While at FDA, she also led various teams/branches of scientists responsible for microbiology product quality assessments of BLAs and for pre-license inspections of biological manufacturing facilities. Prior to joining the FDA, Dr. Hughes held various leadership positions in the biotech/pharmaceutical industry in areas of process development and in pharmaceutical operations. She has been with the FDA for over 20 years.

Presentation(s):

• Review-Based Panel Discussion

  Monday, September 27, 2021
  15:30 – 16:14 EDT

• Review-Based Live Q&A

  Monday, September 27, 2021
  16:14 – 17:00 EDT

• C2: Drug Quality Lifecycle: Current Regulatory Concerns

  Tuesday, September 28, 2021
  13:30 – 15:00 EDT

• Live Q&A (C2)

  Tuesday, September 28, 2021
  14:37 – 15:00 EDT

• Risk Management of Non-Ingredient Suppliers: Current Regulatory Concerns

  Wednesday, September 29, 2021
  08:30 – 08:45 EDT

• Live Q&A (ST6)

  Wednesday, September 29, 2021
  09:05 – 09:30 EDT

• A5: Aging Facilities vs. Modern Facilities

  Wednesday, September 29, 2021
  13:45 – 15:15 EDT

• Live Q&A (A5)

  Wednesday, September 29, 2021
  14:30 – 15:15 EDT