Investigations of Microbial Data Deviations

Instructor: Scott Sutton
Product ID: 701239
  • Duration: 90 min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Apr-2009

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This Biotech training will provide valuable assistance to all regulated companies that need to investigate product issues.

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 ( which provides services to microbiology-related user’s groups and supports the PMFList, a microbiology Email list ( and the PSDG Email list (pharmaceutical stability topics) (

Follow us :
The A to Z's of Microbial Control, Monitoring and Validation of Water Systems

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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