Understanding the Harmonized Microbial Limits Tests - stressing the new compendial chapters, validation, verification and new expectations in USP <1111>
Instructor:
Scott Sutton
Product ID: 701238
- Duration: 85 Min
The Microbial Limits Tests of the three major pharmacopeia are in the final processes of harmonization and are scheduled to be fully implemented in 2009. These provide guidance on compendial testing of bioburdens and specified organisms and guidance on setting specifications. This presentation will cover the tests in board overview and discuss the differences between compendial tests for specified organisms and the manufacturer's obligation to minimize the presence of objectionable organisms.
Areas Covered in the Seminar:
- What is involved in the new MLT?
- Harmonization Status.
- Differences in new “Microbial Enumeration” test <61>.
- Differences in new “Absence of Specified” test <62>.
- Differences in new <1111>.
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies (Pharma, OTC etc) that manufacture non-sterile products. The employees who will benefit include:
- End-users responsible for finished product testing
- QA managers and personnel
- Consultants
- Quality system auditors
Instructor Profile:
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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