Navigating AAMI TIR106:2024 – Understanding Product Bioburden Data

Upcoming Virtual Courses

Overview

Unravel the "Why" behind bioburden testing in medical device or pharmaceutical manufacturing. Bioburden is more than just a laboratory test, it’s also a tool that can assist with characterizing products in terms of sterilization process.   Gain critical understanding and learn how manufacturers should interpret and apply bioburden data. Navigate real-world scenarios with guidance on handling bioburden excursions, investigations, and documentation. Delve into recovery techniques and plate counting, ensuring a holistic grasp of bioburden testing. The training concludes with a dedicated Q&A session, offering clarity on covered topics.


Objectives

Over the course of (3) hours, the attendee will be able to:

  • Understand what bioburden is and why it is important.
  • Understand the meaning of bioburden data, including characterization of bioburden.
  • Understand how the context of the situation affects how one views bioburden.
  • Understand its role in sterility assurance. 
  • Understand how to deal with unexpected results.

Who Should Attend?

Sterilization Professionals, Microbiology Professionals, Quality Assurance Professionals, and Product/Process Engineers 


Virtual Training Information

Our virtual training environment allows you to have direct interaction with your instructors and your fellow attendees. AAMI uses Zoom for virtual classes. You can test your connectivity and ability to use Zoom at zoom.us/test.
For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. If you have any questions, please email education@aami.org.

Speakers

David Parente, MBA

Owner and Senior Consultant, Sterwell LLC

Sopheak Srun, MPH

Principal Sterilization Scientist, Cretex Medical