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Laboratory Investigation Out-of-Specification Results

Posted on Oct 24, 2012 2:17:00 PM

Laboratory Investigation Out-of-Specification Results

Webinar - Palo Alto, CA, United States

In this 90-minute training on laboratory Out-of-specification (OOS) investigations, you will learn what constitutes an OOS observation, what is the OOS investigation process described in the OOS guidance and steps to be taken in the laboratory in the event of an OOS observation.

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.


Instructor: John G Lanese

(Courtesy of

Mon, Oct 29, 2012 - Mon, Oct 29, 2012 (10:00 AM-11:30 AM PDT)

Online Event

2600 E. Bayshore Road, Palo Alto, CA, United States

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Tags: science current events, 2012, US, October, Palo Alto, Life Sciences, Biotechnology, laboratory

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