Successful Microbiology Laboratory Investigations – How Can We Believe the Microbiology Lab?

Webinar to be presented Thursday, April 5 at 2pm EST

Abstract

Conducting an effective investigation is extremely difficult in the microbiology lab.  The procedures are operator-dependent, they are subject to significant variability, and it requires days or weeks to even realize there is a problem.  However, there are means to improve our ability to conduct defensible, compliant and effective investigations in the microbiology lab.  This webinar will focus on the investigation of “Microbiological Data Deviations” (MDD) – an investigation which is designed to determine the validity of the laboratory findings preceding a full-blown OOS investigation.

The FDA Guidance document on OOS specifically excludes microbiology from its scope, but this does not release the manufacturer from his obligation to investigation product failures for microbiology-based quality specifications. This webinar will present a proven method for performing laboratory investigations to establish the validity of microbiology test results, a method that relies heavily on a well-designed SOP system and proactive documentation. Additional benefits to this method include enhanced GMP compliance. The approach presented will also be invaluable in audit and investigation of contract laboratory reports, an area of increased regulatory scrutiny.

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