Tuesday April 23, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Barry A. Friedman, Ph.D
On Tuesday, July 12, 2011, the FDA posted on their web site a notice that they had withdrawn the 1987 Guideline on Validation of the Limulus Amebocyte Lysate Test as an End Product Endotoxin Test for Human Parenteral Drugs, Biological Products and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 Agency’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.
In addition, the FDA references three documents that they believe have more than offset the previous FDA Guidance that was withdrawn.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 Questions and Answers 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 webinar will also include the new General Information Chapter <1085> GUIDELINES ON THE ENDOTOXINS TEST which was issued in December 2019.
Since the replacement of the 1987 Guidance, another issue has come to the fore in the manufacture of monoclonal antibodies. A phenomenon called “Low Endotoxin Recover” (LER) surfaced that created much concern in the industry. This webinar will also address this issue as well as its application within PDA TR 82.
The objective of this interactive, Executive Conference Corp. webinar is to explore the new Guidance for Industry on Pyrogen and Endotoxin 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. Please plan to attend this webinar with your Project Management team.
By attending you will learn:
- 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 comprise the Agency Guidance team involved within this new 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
- Learn the latest on LER (Low Endotoxin Recovery) and PDA TR 82
- Issues surrounding the new General Information Chapter USP<1085>
Those who should attend include:
- Microbiologists
- Quality Control
- Quality Assurance
- Regulatory Compliance
- Validation
- Project Management
- Manufacturing
- Research and Development
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-590