AM23-MN-02-O: Inspection Findings and Updates from FDA’s Office of Regulatory Affairs - Where Does Your Institution Rank Regarding the Most Cited Deficiencies? (Enduring)

Oct 18, 2023 6:00pm ‐ Oct 18, 2023 7:00pm

Credits: None available.

Overview
CE Information

This session will be presented by the FDA’s Office of Regulatory Affairs (ORA), Office of Biological Products Operations (OBPO). The discussion will include the organizational structure of OBPO, including OBPO’s role in regulatory inspections and current regulatory oversight. The top regulatory violations that are most cited, compliance trends, and actions for biological products, including blood, blood components, and cellular therapies, will be discussed.

Speaker(s):

Scott Ballard, National Expert Investigator, US FDA
Samantha Pinizzotto, DVM, MPH, CPH, National Expert, FDA Office of Regulatory Affairs Office of Biological Prdts Operations
Susan Turcovski, Deputy Director, FDA Office of Regulatory Affairs Office of Biological Prdts Operations

Credits

Credits: None available.