Technical Qualification of the Contract Microbiology Lab

The webinar is scheduled for Thursday, April 19 at 2 pm EST

Abstract

Selection of the right contract laboratory partner can be a great asset to the organization, or it can open the company to recalls and seizures.  Recent news has provided examples of poorly performing contract facilities that have resulted in significant penalties for the companies that trusted them with testing of products.     It is important to inspect the technical abilities of your contract lab suppliers (especially in microbiology), not only their Quality System.

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. This is a challenge for many inspectors who may not have years of experience at the microbiology bench to provide a perspective on the task.

We will discuss USP <1117> “Best Microbiological Laboratory Practices” with input from FDA and PIC/S guidance documents as practical resources for the technical audit of the QC microbiology lab.   Learn how to use these freely available resources to protect your company from poor lab work by the contract lab (or even your internal lab).

This is a shortened version of a highly successful in-house “Lab GMP” course taught the last 5 years.

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

  • What do the GMPs really say about microbiology and the perils of overreliance on 483s for guidance
  • Laboratory Systems
  • Aseptic Technique, basic microbiological practices
  • Control of Media
  • Control of Microbial Cultures
  • Control of Equipment
  • Lab Lay-out and Operations
  • Sample Handling
  • Microbiological Media Incubation Times
  • Training of Staff
  • Laboratory Resources
  • Control of Data and Documentation
  • Interpretation of Results
  • Selection of Methods
  • Management Oversight