Even 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.
December 14, 2017
Prepare for an FDA Bioburden Inspection
Even 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.