Summary:
The United States Pharmacopeia and the European Pharmacopoeia have both recently issued new guidance on the validation of alternate microbiological methods. Both of these initiatives owe a great deal to PDA Technical Report #33. The genesis and development of the guidance documents, their philosophy, and the likely future of alternate methods will be explored in this audio/Web seminar.

In particular, the opportunity to introduce alternate methods as routine quality control tests within the QC microbiology area of responsibility will be developed as a theme utilizing published literature to minimize the validation burden.

This audio/Web seminar is ideal for anyone involved with microbial contamination testing of controlled environments.

About the Speaker:
Dr. Sutton earned his B.S. in Genetics from the University of California at Davis, and his Masters and Ph.D. in Microbiology from the University of Rochester (Rochester, NY). After an NIH postdoctoral fellowship at the Medical College of Virginia (Richmond, VA), he went to work for Bausch and Lomb (Rochester, NY) until 1994 when he accepted a position at Alcon Laboratories (Fort Worth, TX). Dr. Sutton left Alcon Laboratories in 2004 as a Director in the R&D division to accept the position with Vectech Pharmaceutical Consultants, Inc. There he has assisted companies as varied as start-ups, generics, and established pharmaceutical innovators with laboratory management and compliance issues, process change opportunities, project management, and implementation of rapid microbiological methodologies. Dr. Sutton is an active author and speaker, with over 30 publications in the literature and over 100 presentations to scientific conferences. He is also active in a volunteer capacity, being involved with the USP Analytical Microbiology Committee of Experts since 1993, and in serving as a reviewer for the PDA Journal and other 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 and supports and Email list devoted to pharmaceutical microbiology (http: //www.microbiol.org/ pmflist_info.htm).