Training Course Syllabus:

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

Description:

This session will provide the participants with best practices regarding policies and procedures for mitigating workplace violence and hostility. Attention will be devoted to current trends (U.S), civil/legal expectations and necessary policies. Further, the impact that a hostile environment has on productivity and the organizational bottom line will be discussed along with easy remedies to mitigate this impact.

Why Should you Attend

The current thinking of the FDA regarding the use of the Limulus Amoebycyte Lysate (LAL) test for endotoxins in lieu of the rabbit pyrogens test has changed. As a result, the last guidance document, Guideline on Validation of the Limulus Amedocyte Lysate (LAL) Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices, which was published in 1987, has been withdrawn by the agency.

Objectives of the Presentation:

• Provide a review of the current testing requirements


• Understanding what happened to the old 87/91 LAL Guidance for industry document


• Learn what has replaced it and why


• Learn common issues, misunderstandings and misinterpretations


• Determine who comprised the agency guidance team involved with in this new proposed Guidance


• Learn the documents supporting this new Guidance


• Learn about sampling, storage, handling and pooling


• How does one transition from one bacterial endotoxin test to another—understand the RPT (Rabbit Pyrogen Test)


• Learn about the Monocyte Activation Test (MAT). Determine when the Rabbit Pyrogen Test is appropriate to use in lieu of the LAL


• Understand the FDA´s expectation for screening of therapeutic products.

Seminar Summary:

Learn current testing requirements, what happened to the old LAL Guidance for industry document, documents supporting this new Guidance, more. (see full course description)

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