2022 - Bacterial Endotoxin Test to Include the Latest on Low Endotoxin Recovery (LER)

Areas Covered in the Webinar:
Review of the current testing requirements to include Low Endotoxin Recovery (LER)
What happened to the old 87/91 LAL Guidance for Industry Document
What has replaced it and why
Common issues, misunderstandings and misinterpretations
Determine who comprise the Agency Guidance team within this new proposed Guidance
Documents supporting this new Guidance
Sampling, storage, handling and pooling
How does transition happen from one bacterial endotoxin test to another
Determine when the Rabbit Pyrogen Test is appropriate to use in lieu of the LAL
The FDA's expectation for screening of therapeutic products