Validation is a politically-charged topic in most companies as entire departments are given over to its execution, a task frequently carried-out without sufficient regard to the needs of the QC microbiology department.   The needs of the compliant Microbiology department in in this regard are many:
Equipment:  Effective qualification of laboratory analytical equipment
Process: Environmental Monitoring and Contamination control process validation and design
Media Fills: Aseptic process support
Method Suitability Studies: For all microbiological assays This conference will focus on providing an overview of the validation efforts that QC Microbiologists must participate in to be effective and compliant in their roles.

This conference will be moderated by 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.