FDA Audit Finding Updates
Through this presentation, Kip Hanks, Biologics National Expert for FDA's Office of Regulatory Affairs, Office of Biological Products Operations, will review current trends in FDA findings and processes.
Kip J. Hanks, BS
Investigator/Biologics National Expert, FDA / Office of Biological Product Operations
Kip Hanks, Biologics National Expert for FDA's Office of Regulatory Affairs, Office of Biological Products Operations, received a BS in microbiology from McNeese State University and began employment with the Agency in 1997 as a generalist investigator in New Orleans, LA. Over the years, his work focused on biologics and bioresearch monitoring. He served as the district biologics specialist for New Orleans and Atlanta Districts and was selected as the biologics national expert in 2011 upon returning to post-Hurricane Katrina New Orleans. In this position, Investigator Hanks serves as a liaison between ORA and CBER, trains and mentors biologics investigators, participates on policy workgroups and continues to perform international inspections. He resides in New Orleans, LA with his wife, daughter and menagerie of pets, enjoying all of the culture that the city offers.