Validation of Rapid Microbiological Methods
Instructor:
Scott Sutton
Product ID: 701240
- Duration: 90 Min
Rapid microbiological methods have the potential for removing one of the primary bottlenecks in finished product testing, but the methods must be shown to be "equivalent" to the previously approved method. This presentation will look at different methods to validate the alternate method.
Areas Covered in the seminar:
- Regulatory guidance.
- Validation Criteria overview.
- Methodologies available.
Who will benefit:
This webinar will provide valuable assistance to all regulated companies (Pharma, medical device, biotech, OTC etc) that need to.The employees who will benefit include:
- End-users responsible for finished product testing
- QA managers and personnel
- Consultants
- Quality system auditors
Scott Sutton, Dr. Sutton earned his Masters and PhD in Microbiology from the University of Rochester (NY). After a NIH postdoctoral fellowship he worked for Bausch and Lomb until 1994 when he went to Alcon Laboratories, and in 2004 accepted a position with Vectech Pharmaceutical Consultants. He has worked with the USP Microbiology Committee of Experts since 1993, serving as vice-chair since 2000. Dr. Sutton also operates an information source on the internet, The Microbiology Network (http://www.microbiol.org) which provides services to microbiology-related user’s groups and supports the PMFList, a microbiology Email list (http://www.microbiol.org/pmflist.htm) and the PSDG Email list (pharmaceutical stability topics) (http://www.microbiol.org/psdglist.htm).
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