The medical device industry is seeing a rise in regulatory scrutiny around microbial QC management and endotoxin testing. With this increase, a thorough understanding of the requirements of <USP 161> and ANSI/AAMI ST72:2011 is crucial for manufacturers of injectable and implantable devices, as they provide guidance for maintaining the long-term safety of their products, mitigating risk, improving QC lab throughput, and understanding inconsistencies.

In this webinar, attendees will gain an understanding of the regulatory requirements and guidance surrounding endotoxin testing for medical devices and learn best practices for setting up a program for their own QC facilities.

Presenter

  • Alan Hoffmeister, Senior Product Specialist, Charles River