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Guidance for Evaluating and Investigating Endotoxin OOS/OOT and Atypical Results

Guidance for Evaluating and Investigating Endotoxin OOS/OOT and Atypical Results


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

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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

Charles River News & Announcements

In today’s world, quality and compliance are non-negotiable, and yesterday’s standards are no longer sufficient to meet the demands of a constantly evolving landscape. The field of quality control microbiology is undergoing a disruptive revolution to safeguard patient safety, evolving beyond traditional methods to optimize resources, minimize human error, enable sustainable alternatives, and maintain consistent quality standards. Every test, every result, and every data point define the success of life-changing therapies. That’s why we’re leading a new paradigm, one that redefines efficiency, sustainability, and innovation. Let’s rethink the future of microbial quality control, where modern, automated, data-centric, and scalable solutions are the norm, empowering you to stay ahead in a dynamic regulatory and operational landscape.  Together, we are not just preparing for the future. We’re rethinking it. Because every moment matters.

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Posted by: RXinsider Staff

RXinsider is a multimedia publishing and technology company offering print publications, digital platforms, events, and content creation services to the B2B pharmacy market.

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