Topics in the Antimicrobial Effectiveness Test

Webinar to be presented Thursday, March 22 at 2pm EST

Abstract

The Antimicrobial Effectiveness Test is a well-established test in both the USP and the Pharm. Eur.    The goal and scope of this test, however, is not well defined in the literature or the industry’s perception of its value.   This webinar will examine the strengths (and limitations) of the AET and its place in the microbiology lab testing scheme, as well as how it fits into a product stability program.  As microbiology supports product regulatory submissions, the AET will be discussed not only from the QC lab perspective but also its place in product development and the regulatory submission.  The GMP aspects of the AET will be discussed with an eye to audits of test results and investigations of questionable results.

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Scott Sutton, Ph. D.

Dr. Scott Sutton earned his Masters and PhD in Microbiology from the University of Rochester (NY). With over 20 years of laboratory leadership experience in the microbiology arena of the pharmaceutical and personal products industries, he now consults through Microbiology Network, Inc. Clients have included startups, generics, established Fortune 500 companies, law firms and investment broker houses. Laboratory management, training, GMP, testing methodologies and microbiology-related project management are areas of special interest. He has worked with the USP Microbiology Committee of Experts since 1993, serving as vice-chair since 2000. He operates the Pharmaceutical Microbiology Forum with its monthly newsletter (http://www.microbiologyforum.org) and serves as a reviewer for several 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. This service also supports three Email lists, the first devoted to pharmaceutical microbiology, the second devoted to pharmaceutical stability and the third to cleanrooms and controlled environments.

Key Topics

  • Antimicrobial Effectiveness Test
    • What it can do
    • What it can’t do
  • Technical Considerations
    • Proactive Documentation
    • Demonstration of Method Suitability
    • Investigations
  • Regulatory Issues
    • When performed In Product Development?
    • Where included in the eCTD
    • Technology Transfer & Change Control
  • Other Considerations