Jennifer Del Valle Ortiz, MS U.S. FDA

Jennifer Del Valle Ortiz is currently serving as a Branch Chief within the Division of Compounding I, Office of Compounding Quality and Compliance (OCQC) in CDER’s Office of Compliance.  As a recognized authority in scientific and regulatory matters associated with pharmacy compounding, she serves as the lead to a team of Consumer Safety Officers providing direction, instruction and guidance in the review and evaluation of compliance cases in pharmacy compounding, thus supporting the program’s efforts to protect the American public from poor quality drug products and ensure compliance of firms with sections 503A and 503B of the Federal, Food, Drug and Cosmetic Act (FDCA).

Mrs. Del Valle is a subject matter expert in sterile drug production and microbiology, with over twenty years of experience in pharmaceutical quality and regulatory matters.  She holds a BS in Industrial Microbiology from the University of Puerto Rico, and a MS in Pharmaceutical Outcomes and Policy from the University of Florida.