Quality Metrics and the Issues with the FDAs Revision Draft Guidance Quality Metrics Data

Barry A. Friedman, Ph.D

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This webinar will discuss the main issues with FDA’s revised draft guidance on submission of quality metrics data. It will also cover the most common observations that the FDA issues within the warning letter and how these can impact your organization.

Why Should You Attend:

In July 2015, the FDA initiated an initial DRAFT Guidance for Industry in which they reviewed the various benefits that Industry and the FDA would derive from industry providing “Metrics” to the FDA. One of the “carrots” that the FDA held out was the potential for minimizing and, even, potentially eliminating a firm from a FDA audit if the results of a risk based review of their Quality Metrics were documented to be outstanding. Because of the large number of comments, the FDA has again issued another revised DRAFT Guidance.

This live, interactive webinar will review the issues surrounding the revised DRAFT Guidance to allow for a more ready understanding as well as illustrate some of the difficulties associated with it where industry is concerned. It will also delve into the most frequent “Metrics” which the FDA translates into Observations within Warning Letters. While the Guidance appears to be a panacea, this discussion will illustrate that it is anything but that, and why so many in industry are concerned about its finalization and implementation.

Areas Covered in the Webinar:

  • The main issues within the revised DRAFT Guidance
  • What the FDA does not share with you
  • What may occur to your organization should you choose not to submit the “Metrics” information
  • How not sharing may impact potential drug shortages
  • The most common “Metrics” (Observations) that the FDA issues
  • How these observations may impact your organization

Who Will Benefit:

  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Manufacturing engineers
  • Quality engineers
  • Quality auditors
  • Quality control personnel
  • Document control specialists
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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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