Medical Devices 2021 - FDA's Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices

The FDA posted on their web site on Tuesday, July 12, 2011 a notice that they had withdrawn the 1987 Guideline on Validation of the Limulus Amebocyte Lysate Test as an End Product Endotoxin Test for Human Parenteral Drugs, Biological Products and Medical Devices.
The objective of this live training webinar is to explore the NEW/REVISED Guidances for Industry on Pyrogen and Endotoxins Testing which addresses those issues that may be subject to misinterpretation
Definitions
Examine the Background of the 1987 Guidance for Industry document,
Review current testing requirements,
Speaker:
Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. From 2000 to 2007