Laboratory Developed Tests: Challenges and Opportunities
01:30 PM ET | 10:30 AM PT | 12:30 PM CT Duration 60 Minutes
Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar
" Todd Graham is a masters-level bench scientist and medical technologist with a host of experience in both the clinical diagnostics and biotechnology fields"
What the FDA is asking for with regard to these new regulations
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 FDA’s perspective with these tests and the regulatory approach therein.
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 laboratory’s 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.
1) What is the legal definition of a laboratory developed test?
2) How will FDA regulations around these tests change?
3) How will validation of these tests change?
4) What is needed for a successful validation of a LDT under the new regime?
5) What concerns need to be addressed as a part of test development?
6) How can you turn compliance into a key asset for your test?
Who will Benefit
• Bench Scientists
• Quality Assurance
• Medical Technologists
• Business Development
Industries who can attend
This 60 minute online course is intended for professionals in the Pharmaceutical and Biopharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel