FDA's New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices
Live, Interactive Training Webinar
Date: February 13, 2014
Time: 1:00pm - 3:00pm ET (New York Time)
Click Here to Register for this Interactive, Live Webinar
The FDA posted on their web site on Tuesday, July 12, 2011 a notice that they had withdrawn the 1987 Guideline on Validation of the Limulus Amebocyte Lysate Test as an End Product Endotoxin Test for Human Parenteral Drugs, Biological Products and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. They advised that the 1987 Guideline is considered obsolete and does not reflect the FDA's current thinking on the topic.
In lieu of this document, the FDA advised that they would be issuing a Guidance for Industry on Pyrogen and Endotoxins Testing: Questions and Answers during the November/ December 2011 timeframe. After much delay, this NEW Guidance was released in June 2012. The FDA referenced, however, three documents that they believe have more than offset the previous FDA Guidance that was withdrawn. They advise that these documents be referenced for the fundamental principles of the gel clot, photometric and kinetic test methods.
This NEW, revised Guidance supplements the above three documents and addresses those issues that may be subject to misinterpretation, not covered in compendial procedures or in the previously available Guidance document. The objective of this live training webinar is to explore the NEW 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.
-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 within 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.
-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.
Webinar outline and time breakdown:
Date: February 13, 2014Time* Activity
|12:45 PM||Log In Period|
|Examine the Background of the 1987 Guidance for Industry document,|
|Review current testing requirements,|
|Overview of the NEW Guidance for Industry for LAL,|
|02:10 PM||Examine the Bases for the Bacterial Endotoxin Tests,|
|Learn of the documents supporting the proposed, new FDA Guidance,|
|Learn of the typical issues confronting the end user of LAL testing,|
|03:00 PM||Live Questions & Discussion|
*Please note all times are Eastern Time (New York Time)
This live training webinar includes the following for each registered attendee:
- A copy of the presentation slides
- A certificate of participation for attendee training records
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
- Quality Assurance personnel
- Quality Control personnel
- Research & Development
- Regulatory Affairs Professionals