Qualification of Equipment in the Microbiology Lab

Webinar to be presented Thursday, September 27 at 2 pm EST


The microbiologist went to school for years to learn how to work in the laboratory, but upon acceptance into industry is now also expected to have many additional skills. One of the more challenging is the expectation that the lab will be able to qualify (or at least write and review the protocol) its laboratory equipment. Fortunately there is guidance on how to decide which equipment requires qualification of function and how to design the protocol. This webinar will focus on the instruments of the QC microbiology lab using the USP chapter <1058> as a guide for analytical instrument qualification.

Register Here!

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.

Key Topics

  • Components of Data Quality
  • Analytical Instrument Qualification Process
  • Roles and Responsibilities
  • Software Validation
  • Change Control
  • Documentation
  • Instrument Categories