Clever Way to Automate Plate REading

Sterility Failure Investigations – A Step-by-Step Process for Success - Webinar

2018, January 24 @ 13:00 - 13:30

Pharmaceutical » Webinar

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

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Life Science Training Institute
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