Bacterial Endotoxin Test to Include the Latest on Low Endotoxin Recovery (LER)


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The webinar will review the current testing requirements as defined in the new, revised FDA guidance on Endotoxin and Pyrogen testing. It will further help attendees understand the issues surrounding the Low Endotoxin Recovery (LER) and its regulatory outcome.

Why Should You Attend:

The objective of this interactive 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. It will also discuss the results of Low Endotoxin Recovery (LER).

Areas Covered in the Webinar:

  • Review of the current testing requirements to include Low Endotoxin Recovery (LER)
  • What happened to the old 87/91 LAL Guidance for Industry Document
  • What has replaced it and why
  • Common issues, misunderstandings and misinterpretations
  • Determine who comprise the Agency Guidance team within this new proposed Guidance
  • Documents supporting this new Guidance
  • Sampling, storage, handling and pooling
  • How does transition happen from one bacterial endotoxin test to another
  • Determine when the Rabbit Pyrogen Test is appropriate to use in lieu of the LAL
  • The FDA's expectation for screening of therapeutic products

Who Will Benefit:

  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Manufacturing engineers
  • Quality engineers
  • Quality auditors
  • Quality control personnel
  • Microbiology specialists
  • R & D personnel
Webinar Events
Speaker: Barry A. Friedman, Ph.D,, Consultant in Biotechnology, Regulatory Compliance..

Barry A. Friedman, PhD, is a Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology.

Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of 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 interactions, both domestic and international.

Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n’ Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide.

Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology.


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