Successful Microbiology Laboratory Investigations – How Can We Believe the Microbiology Lab?
Webinar to be presented Thursday, April 5 at 2pm EST
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.
Scott Sutton, Ph. D.
Dr. Scott Sutton earned his Masters and PhD in Microbiology from the University of Rochester (NY). With over 20 years of laboratory leadership experience in the microbiology arena of the pharmaceutical and personal products industries, he now consults through Microbiology Network, Inc. Clients have included startups, generics, established Fortune 500 companies, law firms and investment broker houses. Laboratory management, training, GMP, testing methodologies and microbiology-related project management are areas of special interest. He has worked with the USP Microbiology Committee of Experts since 1993, serving as vice-chair since 2000. He operates the Pharmaceutical Microbiology Forum with its monthly newsletter (http://www.microbiologyforum.org) and serves as a reviewer for several peer-reviewed journals. Dr. Sutton also operates an information source on the internet – The Microbiology Network (http://www.microbiol.org) that provides services to microbiology related user’s groups. This service also supports three Email lists, the first devoted to pharmaceutical microbiology, the second devoted to pharmaceutical stability and the third to cleanrooms and controlled environments.