Laboratory Developed Tests: Challenges and Opportunities
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Course Description:
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.
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.
Areas Covered:
- What is the legal definition of a laboratory developed test?
- How will FDA regulations around these tests change?
- How will validation of these tests change?
- What is needed for a successful validation of a LDT under the new regime?
- What concerns need to be addressed as a part of test development?
- How can you turn compliance into a key asset for your test?
Who will benefit?
This webcast will be of immense value for the below mentioned Professionals.
- Bench Scientists
- Quality Assurance/QC
- Medical Technologists
- Business Development
Registration Options
Speaker Details
Todd Graham
Biotech, Pharma
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.
Refund Policy
Participants/Registrants for our live events, may cancel up to 72 hours prior to the start of the live session and ComplianceTrain will issue a letter of credit to be used towards any of ComplianceTrain's future events. The letter of credit will be valid for 12 months.
ComplianceTrain will process refund in cases where the event has been cancelled and is not rescheduled within 90 days from the original scheduled date of the webinar. In case if a live webinar is cancelled, participants/registrants may choose between recorded version of the course or a refund. Refunds will not be processed to participants who do not show up for the webinar. A webinar may be cancelled due to unavoidable circumstances, participants will be notified 24 hours before the scheduled start of the event. Contact us via email: admin@ComplianceTrain.com
