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.
Technology and Market Development Manager II
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