Webinar Overview
Whenever a lab obtains an out of specification (OOS) test result, the FDA requires an investigation be conducted to determine its cause. This process should not be taken lightly, and needs to be thorough, timely, unbiased, well-documented, and scientifically sound. Failure to conduct a proper OOS investigation can have dire consequences, including increased production stoppages, damage to your reputation, and even compromised patient safety.
In this webinar, we detail how to perform an investigation for an endotoxin OOS result and how companies can evaluate their release data (including OOS, out of trend (OOT), and atypical results) to improve their processes and prevent the occurrence of these unwelcome, unexpected events in the future.
WEBINAR PRESENTER
Jordi Iglesias
Technology and Market Development Manager II
Charles River
We are providing digital education options to keep you learning about topics you may be interested in. For more information, visit criver.com/digital-education.
Charles River’s QC microbiology testing portfolio brings you modern products and services that deliver accurate, relevant, and reliable data to allow you to make confident decisions on your product quality and contamination control. Our unique combination of Endosafe® endotoxin testing, Celsis® rapid microbial detection, and Accugenix® microbial identification and strain typing keeps your manufacturing operations running efficiently and smoothly, lowers your cost to manufacture, and protects your reputation.
This post is related to:
Quality Control, Lab Testing Services
