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Managing Microbiological Out of Specification (OOS) and Out of Trend (OOT) Results

July 10, 2024 Wednesday 8:00 AM PT | 11:00 AM ET
Duration: 90 Minutes Webex

Sponsored by ComplianceOnline

Click Here to register $199.00 (with recording $419)

The objective of this interactive, live training webinar is to explore the management of OOS practices and suggested avenues to take to minimize deviations, OOT, OOS and CAPA and how to attack these situations should they occur. It is also designed to determine how FDA and ICH regulations and guidances may impact them. It will also reference the new PDA TR 88, “Microbial Data Deviation Investigations in the Pharmaceutical Industry”.


Microbiological Out of Specifications (OOS) may occur with the production of both non-sterile and sterile products. They may occur as early in the process as with Incoming Raw Materials and extend throughout In-process and Active Pharmaceutical Ingredient (API) phases to the final product.

With the advent of the revised USP<61> Microbial Examination of Nonsterile Products: Microbial Enumeration Test, a new latitude in result interpretation has come to the fore; however, one needs to understand how to utilize this inherent variation of USP<61> with Out of Trend (OOT) and Out Of Specification (OOS).

Microbial data deviations or non-conformances periodically may occur as well as OOT, OOS and Corrective and Preventive Actions (CAPA). However, unlike chemical analytical deviations, all microbial non-conformances to include OOS and CAPA investigations may require as many as six months to complete these studies based on their degree of difficulty and additional laboratory tests that may be required.

Sterility testing practices (USP<71> Sterility Tests) comprise the historical "gold standard" for releasing pharmaceutical and biotechnology products as sterile. Because extensive contamination is often required before a sterility test fails, regulatory agencies require initial and then periodic media fills as well as smoke studies, observation of technicians, and extensive environmental studies to add additional confirmation to sterility assurance prior to the commencement of aseptic filling. Therefore, OOS may not only directly examine sterility, but all of the results that indirectly impact it.

Areas Covered in the Webinar:
  • Review of the new latitude within USP <61> and how it may impact OOT and OOS.
  • Review issues that may occur within the Incoming Raw Materials, In-Process and API phases.
  • How developing a comprehensive validation of the facilities, the aseptic processing area and gowning qualification can minimize non-conformances.
  • How to manage when a failure still occurs.
  • How and when to bridge the "gap" between deviations, OOS and CAPAs.
  • How the use of metrics may provide a “roadmap” for corrective action.
  • Where Risk Management applies to deviations, OOS and CAPAs.
  • Review Guidance for Industry Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.
  • Phase I and Phase II of an Out of Specification Investigation.
  • Examine the new FDA “attitude” that is being taken with non-sterile product.
  • Identify the OOT and OOS regulatory concerns in a cGMP environment.
  • Review the microbiological issues that may occur within Incoming Raw Materials, In-Process and API phases.
  • Discuss key issues in manufacturing non-sterile products.
  • Identify gaps within current regulatory and industry expectations.
  • Explore Form FDA 483s and Warning Letters that have recently been issued.

Instructor Profile:

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. 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.

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.