This course will describe the actions that should be taken when a sterility test failure occurs. What happens when a suspect microbial result is reported? What does it look like, and how should you react? This webinar will review when it is appropriate to investigate a result that may seem “out of the ordinary.”
By attending this interactive, 90-minute session, you will learn:
- FDA Regulations and Guidance on Sterility Failure Investigations
- Stages of Investigation: Lab Investigation vs. Manufacturing Investigation
- Tools to use to help determine Root Cause
- How to categorize sterility results
- How to address impact to lots affected
- Areas, parameters and variables to investigate as part of the investigation
- Proper documentation of the Investigation
- CAPA plans that address root cause
For more information and registration visit www.lifesciencetraininginstitute.com
