Topics in the Sterility Test

Webinar to be presented Wednesday, May 16 at 4 pm EDT

 

(May 7, 2012) LAST MINUTE CHANGE  – The CBER Sterility Test was finalized on May 3, 2012.  This webinar will be extended to 90 minutes to include a review and discussion of this important new document.

 

Abstract

The compendial Sterility Test has acquired near-religious stature in the industry since its inception in the early 1930’s. This webinar will examine the now internationally-harmonized test in terms of its scope as a regulatory requirement and a scientific test method. The GMP aspects of the test will be discussed in terms of adequate documentation and control for audit review and investigation, as well as its role in the product development process and ongoing QC of finished product during manufacture and release to market.

Register Here!

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

  • Sterility 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