Thursday, January 25, 2018
NOON – 1:30 pm EST
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On Tuesday, July 12, 2011, the FDA posted on their web site a notice that they had withdrawn the 1987 Guideline on Validation of the Limulus Amebocyte Lysate Test as an End Product Endotoxin Test for Human Parenteral Drugs, Biological Products and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 just released in June 2012.
In addition, the FDA references, however, three documents that they believe have more than offset the previous FDA Guidance that was withdrawn.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 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.
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.
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.
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 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
- Learn the latest on LER (Low Endotoxin Recovery)
$385 for one person
$700 2-5 people
$999 6-10 people
About the Instructor: Barry A. Friedman, Ph.D.
Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance, Microbiology and Aseptic Processing arena. From 2000 to 2007, Dr. Friedman was associated with Cambrex Bio Science Baltimore, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, MD. In that capacity as the Director, Quality Control, he managed a multi-shift Department of thirty one individuals involved in Client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity Dr. Friedman enjoyed many client and regulatory compliance interactions.
Dr. Friedman has over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness assistance, quality control, sterility assurance, microbiological/analytical validations and fermentation technology. In addition to the associations listed above, other associations have included Chesapeake Biological Laboratories, W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.
Dr. Friedman is a frequent seminar and webinar speaker and specializes in the areas of regulatory compliance, internal auditing, aseptic processing for sterile drug products, USP and Warning Letter “dissection”, multi-departmental interactions, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi, TungstenShield, IPA (Canada), Executive Conference Corp., Compliance OnLine, and Pharmig (UK). He maintains an active Blog (www.barryafriedmanphdllc.com/) that contains over 200 Blogs that address various Warning Letter and FDA 483 issues as well as over 1,500 “Search” terms. He is a member of ASM, PDA and RAPs. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President and current Treasurer of the Capital Area Chapter, PDA. He recently received the James Agalloco award from PDA which is awarded to a PDA faculty member who exemplifies outstanding performance in education.