Managing Microbiological Out of Specification (OOS) and Out of Trend (OOT) Results in Sterile and Non-Sterile Production– FDA & ICH Expectations and Guidance

Live, Interactive Training Webinar

Available Live On-Demand
Instructor: Barry A.Friedman Ph.D. Biography>>>

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Microbiological Out of Specifications 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.

The objective of this 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.

Learning Benefits:
-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.

Webinar outline and time breakdown:

1:15 PM Log In Period
1:30 PM Introduction
1:40 PM Definitions,
Understand the latitude inherent within USP <61>,
Issues that may occur within Incoming Raw Materials, In-Process and API phases,
Factors impacting the manufacture of a sterile product,
2:30 PM Break
2:40 PM Review Guidance for Industry Investigating Out-of-Specification (OOS),
Phase I and Phase II components of OOS,
Form FDA 483s and Warning Letters,
3:30 PM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of participation for attendee training records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Quality Assurance personnel
  • Quality Control personnel
  • Research & Development
  • Regualtory Affairs Professionals
  • Validation
  • Auditors

Schedule & Deliver this Live Training Webinar Privately to Your Group

Instructor: Barry A. Friedman Ph.D.

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. Dr. Friedman is a frequent seminar speaker in the GMP areas of internal auditing, aseptic processing of sterile drug products, USP microbiology, 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. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA... Full Bio>>>



Course Number: 234

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Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

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"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

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"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

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