Quality Metrics and the Issues with the FDA’s Revision Draft Guidance Quality Metrics Data

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In July 2015, the FDA initiated an initial DRAFT Guidance for Industry in which they reviewed the various benefits that Industry and the FDA would derive from industry providing “Metrics” to the FDA.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 Because of the large number of comments, the FDA has again issued another revised DRAFT Guidance.

This live, interactive webinar will review the issues surrounding the revised DRAFT Guidance to allow for a more ready understanding as well as illustrate some of the difficulties associated with it where industry is concerned.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• The main issues within the revised DRAFT Guidance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

Barry A. Friedman
Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena

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, expert witness testimony, 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 (Pharma Webinars), Executive Conference Corp., IPA (Canada) 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 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.

Topic Background:

The FDA Safety and Innovation Act (FDASIA) of 2012 provides a firm the legal basis for setting clear standards and for collecting data to assess manufacturing operations. Section 705 of FDASIA requires FDA to establish a risk based schedule for inspecting drug manufacturing sites, and requires access to more detailed information on facilities and quality controls. Section 706 authorizes the Agency to obtain information on drug production sites and operations in advance of an inspection. Together, these two Sections support FDA’s strategy for improving how it assesses the ability of a manufacturing site to consistently produce medicines fit for intended use. This following REVISED DRAFT Guidance represents a follow-up to FDASIA.

Follow us :