Investigations of Microbiological Laboratory Data
Webinar to be presented Thursday, August 16 at 2pm EST
What did the Microbiology lab do wrong? This is generally the first question asked when unpleasant data is reported about finished product.
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. Before getting to this stage, however, we have to have complete confidence in the microbiology lab data.
This webinar will present a proven method for performing laboratory investigations to establish the validity of microbiology test results, whether from an internal resource or a contract testing lab. This method 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.
Be sure of your data before reporting product issues!
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.