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
Director of Regulatory and Governmental Affairs
After earning a BS in microbiology from McNeese State University and finishing up 6 years as a special operations forward air controller in the Louisiana Air National Guard, Kip Hanks began employment with the FDA as a field investigator in 1997. After a few years as a generalist covering multiple FDA-regulated products, he became a district biologics specialist and then the Office of Regulatory Affairs (ORA) biologics national expert. In this role, Kip was responsible for providing regulatory and guidance interpretation and application to ORA staff, training and mentoring new investigators, serving on policy and document workgroups and advising ORA senior leadership on biologics-related matters. In July 2021, he joined the American Association of Tissue Banks as its first director of regulatory and governmental affairs. In this role, Kip establishes and communicates the AATB official position regarding regulatory issues that may impact AATB member organizations to the FDA and other applicable governmental and standard-setting organizations. He provides expert interpretation, guidance, strategy and counsel on existing laws, regulations, standards, and guidance that impact AATB members.