Investigation of Out-of-Specification Results in the Laboratory

Event Information
Product Format
Prerecorded Event
90 minutes
Product Description

Understand How a Compliant Lab Handles Out-of-Specification Test Results


Inadequate Investigation of Out-of-Specification (OOS) results is a common reason for laboratories receiving FDA 483s and Warning Letters. There is a growing concern that companies and laboratories are not applying good science in the investigation of OOS lab test results or tests that are outside statistically expected ranges. The level of OOS observations that are invalidated due to laboratory error will be very visible when the FDA starts collecting OOS test information through the proposed Quality Metrics program.

Join this session by expert speaker Jerry Lanese to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results, and how the laboratory interfaces with other units through the laboratory investigation process. Jerry will go in-depth into the FDA guidance on handling OOS laboratory results. You’ll get a clear understanding of compliant laboratory OOS investigations after attending this audio conference.

Why Should You Attend:

Inadequate procedures for laboratory Out-of-specification (OOS) investigations remain high on the list of FDA observations. The FDA has issued a guidance on the topic. OOS procedures and investigations are still a topic of FDA Investigator review and findings. An out-of-specification laboratory observation triggers emotional and political actions that inhibit a productive investigation with a timely conclusion.

There is still confusion in the laboratories as to how an out-of-specification result should be handled and investigated. In this webinar we will discuss the investigation that goes on within the laboratory. Although the focus will be on the FDA Guidance, the discussion will include suggestions for a process that will meet the FDA expectations.

Session Highlights:

  • Understand why the regulators are concerned about the handling of OOS investigations.
  • Understand the FDA model for handling OOS investigations.
  • Understand the commonly accepted terminology such as repeat testing and retesting.
  • How the laboratory can meet regulatory expectations for OOS investigations.
  • The interaction between the laboratory and other units in the organization.
  • Information that will help the laboratory assess and improve its OOS investigation process.

Areas Covered in the Webinar:

  • Regulations and Guidances that will be covered.
  • US.
    • 21CFR211.160
    • FDA Guidance to the Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

 Key Points in the Presentation:

  • What constitutes an OOS observation.
  • The guidance process.
  • Steps to be taken in the laboratory in the event of an OOS observation.
  • The initial laboratory investigation.
  • Repeat testing.
  • Retesting.
  • Confirmation of the OOS Observation.

You will also get answers to the following tough questions:

  • When using outside laboratories for testing, should there be a separate OOS procedure or should they follow the internal procedure?
  • If the testing is performed at CRO, do we include shipping and sampling errors in the OOS investigation before we move on to retesting?
  • How many data points do you need to collect to determine it is an OOT? If a potential OOT occurred at the early time point, do you have to wait until the number of data points are sufficient? If so, could it be a long wait?
  • Does the retesting have to be tested on different days or can it reformed on the same day?
  • We're working on the (nutritional goal) industry. Is the FDA has any guidelines for us similar to the OOS for the pharmaceutical industry?

Who Should Attend

  • Personnel who have responsibilities in laboratory operations, including Directors, managers and line personnel.
  • QA directors, managers and those involved with deviation investigations and Training.
  • Personnel in analytical development.
  • Validation specialists.
  • Laboratory personnel involved with the testing of development formulations, incoming materials, in-process materials and finished product

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About Our Speaker

Dr. Jerry Lanese - Pharma Guidelines Expert

Dr. John G. (Jerry) Lanese is an independent consultant with a focus on Quality Systems and the components of an effective Quality System. He received a BA and MS from Middlebury College and a Ph.D. in Analytical Chemistry from the University of Michigan and began his career teaching Analytical Chemistry in a small liberal arts college. Dr. Lanese moved from the academic environment to the pharmaceutical industry where...   More Info
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