Investigations of Microbial Data Deviations

Microbiological test failures are a difficult situation that many companies make much worse by improper handling of the paperwork, inability to distinguish true failures from lab error and poor lab documentation practices. This presentation will review the proper approach to lab documentation and how it will assist in investigations of MDD (Microbial Data Deviations) as well as how to structure and conduct laboratory investigations in an efficient manner to avoid unnecessary large-scale investigations. Specific examples will be provided for several different situations (Sterility Test investigations stressed).

Areas Covered in the seminar:

• What is involved in investigations that have a microbiological component? How can we eliminate lab error as a convenient explanation (and thereby eliminate false failures)?
  • The Investigation.
    • First eliminate lab error, then investigate as a product failure.
• Specific Investigations.
  • Identification problems are a leading cause of inconclusive investigation findings.This discussion will focus on means to minimize errors in microbial identification and how to document correct practice.
  • Environmental Monitoring excursions are commonly investigated as "OOS" yielding enormous numbers of events. Proper handling of these excursions will be stressed.
  • Finished product test investigations examined will include discussion of several, but stress Sterility Test situations.
• Corrective Action Plan.

Who will benefit:

This webinar will provide valuable assistance to all regulated companies (Pharma, medical device, biotech, OTC etc) that need to investigate product issues. 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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