Laboratory Developed Tests have long been popular tests to perform in clinical diagnostics. These tests can offer unique insights not available using standard diagnostic kits and can offer patients opportunities to improve their health. Historically, the US FDA has used regulatory discretion to not regulate the use of these tests so long as they were performed by qualified personnel. However, changes in both technology and the business of laboratory developed tests have changed the FDAs perspective with these tests and the regulatory approach therein.
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Why should you Attend?
This 1-hr virtual seminar will explain how Laboratory Developed Tests work, regulatory concerns about these tests, and how to build compliance into development
With this webinar, you will learn what the FDA is asking for with regard to these new regulations, and how they can be integrated into your laboratories regulatory validation. While compliance can be simple for a wide variety of LDTs, others will require a variety of changes. This webinar seeks to help you navigate these changes in order to roll out and maintain laboratory developed tests.
Who will benefit?
This webcast will be of immense value for the below mentioned Professionals.
Todd Graham , is a masters-level bench scientist and medical technologist with a host of experience in both the clinical diagnostics and biotechnology fields. He has work for a number of start-up firms in the clinical diagnostics and biotechnology industries, as well as worked for larger firms within both industries.
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