FDA New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices
: 25 Jun 2019
Sector: Clinical, Pharmaceutical
Type: Training, Webinar, Seminar
The objective of this live training webinar is to explore the new/revised guidances for industry on pyrogen and endotoxin testing, addressing those issues that may be subject to misinterpretation, and are not covered in compendial procedures or in the currently available guidance documents, and considering how they impact testing within the typical quality control laboratory.
Examples of FDA warning letters which illustrate problems associated with endotoxin will be provided. The webinar will also discuss the issue of low endotoxin recovery LER and the conclusions reached by the USP Microbiological Expert Committee.
The various endotoxin test guidances will be presented.