December 14, 2017

Prepare for an FDA Bioburden Inspection

bioburdenEven with effective prevention, bioburden incidents can occur. A best-practices response will not only help you be prepared for any upcoming FDA inspection, it may also yield valuable insights to help improve processes and procedures. Anastasia Lolas, former FDA Biologics License Application (BLA) reviewer and inspector focusing on microbiology, shares her expert tips.

Tags: microbial contamination, bioburden, inspection, regulatory, FDA