Is Your Firm Ready for an FDA Office of Inspections and Investigations Inspection?  Hear about the Most Frequently Cited Observations and Inspectional Process from FDA’s Office of Biologics Inspectorate

Program Chair(s)

• 

  Tricia Martinez

  Senior Advisor
  Office of Biologics Inspectorate, Office of Inspections and Investigations
  US Food and Drug Administration
  San Antonio, Texas, United States

  Disclosure(s): No financial relationships to disclose

  PDF

Speaker(s)

• 

  Scott Ballard, MS, CABP

  National Expert Investigator
  Office of Biologics Inspectorate, Office of Inspections and Investigations
  US Food and Drug Administration
  Dallas, Texas, United States

  Disclosure(s): No financial relationships to disclose
• 

  Laurissa Flowers

  Biologics National Expert Investigator
  Office of Biologics Inspectorate, Office of Inspections and Investigations
  US Food and Drug Administration
  Irvine, California, United States

  Disclosure(s): No financial relationships to disclose

This informative session will give an overview of inspections conducted by FDA’s Office of Inspections and Investigations (OII), Office of Biologics Inspectorate (OBI), including OBI’s role in regulatory inspections and current regulatory oversight. We will discuss the top FDA regulatory violations that are most cited for biological products, including blood, blood components, and cellular therapies, along with example FDA-483 observations and best practices to avoid being cited for these deficiencies. We will also review what to expect before, during, and after an inspection.

CABP CE Eligible