FDA New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices
: 3 Apr 2019
Sector: Pharmaceutical, Water
Type: Training, Webinar, Seminar
This interactive, live training webinar will consider the current FDA guidance on endotoxin testing for human parenteral drugs, biological products and medical devices.
Low endotoxin recovery has recently dominated endotoxin discussions since this was observed within a monoclonal antibody formulation in 2013. The USP Microbiology Expert Committee has remained interested in this subject and in 2016 provided their opinion after extensive peer and regulatory reviews. This subject, along with the various endotoxin test guidances will be presented.