FDA New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices
: 9 Dec 2019
Type: Conference, Training, Webinar, Seminar
The objective of this live training webinar is to explore the NEW/REVISED Guidance for Industry on Pyrogen and Endotoxins testing which addresses those issues that may be subject to misinterpretation, and are not covered in compendial procedures or in the currently available guidance documents and how they impact testing within the typical quality control laboratory.
Examples of FDA warning letters which illustrate problems associated with endotoxin will also be provided. It will also discuss the issue of LER and the conclusions reached by the USP microbiological expert committee.