GMP Concerns in the Microbiology Lab
Webinar to be presented October 19th at 2pm EST
Poor practice in the microbiology lab, whether an internal lab or a contracted lab service, can imperil marketed product and lead to recall from the market.
It is important to know what is expected in terms of microbiological lab practice so that you can confirm that your lab services are qualified to perform testing of pharma products. FDA’s “System-Based” approach to audits encourages the audit of the laboratory controls not only from the GMP-documentation perspective (the traditional “Quality” audit) but also from the technical perspective. We will introduce this technical perspective, and provide appropriate pointers for future review.
This is a shortened version of a highly successful in-house “QC Micro Lab GMP” course taught the last 5 years to major pharma companies and contract lab services alike. Proven, solid guidance.
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.