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FDA?s New Endotoxin Test Guidance for Human Parenteral Drugs, Biologic
Wednesday
01.00 PM
http://c2gowebinars.com/product/?topic=endotoxin
10777 Westheimer Suite 1100, Houston, Texas, USA,
Houston Yukon Territory 77042
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DESCRIPTION
Topic Background:
FDA current thinking regarding Endotoxin testing has changed. Industry needs to adopt this new thinking in order to prevent observations, which lead to further scrutiny by the agency.
Description:
The current of the FDA regarding the use of the Limulus Amoebycyte Lysate (LAL) test for endotoxins in lieu of the rabbit pyrogens test is 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for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices, which was published in 1987, has been withdrawn by the agency.
The FDA has found that the published USP and AAMI documents describing methods and calculation of pyrogen and endotoxins testing limits provide industry with appropriate information. There are continuing efforts to harmonize USP Chapters and and FDA guidance documents to reflect the current thinking of the agency. Until this harmonization is complete, the FDA is providing supplemental information in this guidance to explain the current thinking regarding submission and maintenance of pyrogen and endotoxins testing for FDA regulated products.
Why should you attend :
This guidance does not cover the entire subject of pyrogen and endotoxins testing. Instead, it addresses those issues that may be subject to misinterpretation and are not covered in compendial procedures or in currently available documents. There should already be a thorough understanding of these compendial references. The recommendations should be incorporated by organization in order to adopt the current thinking of the agency to prevent observations.
Key learning objectives of the Topic :
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 of common issue misunderstandings and misinterpretations
Determine who comprised the Agency Guidance team involved with in this new proposed Guidance
Learn of 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.
Areas covered during the Session:
Background
Definitions
Examine the 1987 Guidance for Industry Document
Review Current Testing Requirements
Overview of New Guidance for Industry LAL
Examine the Bases for Bacterial Endotoxin Tests
Learn of the documents supporting the proposed, new FDA Guidance
Learn which specific Chapter is yet to be harmonized
Learn of the typical issues confronting the end user of LAL testing.
Warning Letter Examples
Who will benefit :
Senior Management
Regulatory Affairs management and personnel
Compliance Officer and personnel
Quality Assurance management and personnel
Research and Development
Validation
Auditing Management and professional
Quality Control management and professional
Webinar Includes:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
Certificate of Attendance
For?Registration?:http://c2gowebinars.com/product/?topic=endotoxin
Note:?Use?coupon?code????and?get?15% off?on?registration.
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