Laboratory Developed Tests: Challenges and Opportunities

Instructor: Todd Graham
Product ID: 705973
Training Level: Basic to Intermediate
  • Duration: 60 Min
Attend this webinar to learn challenges and opportunities with “Laboratory Developed Tests”. You will learn FDA regulatory requirements associated with these tests. This training will cover successful validation of LDT under the new regime, test development plan, and legal definition of a laboratory developed test.
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Why Should You Attend:

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.

Learning Objectives:

  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
Instructor Profile:
Todd Graham

Todd Graham
Managing Partner, Delevan Street Biosciences

Todd Graham is a clinical laboratory scientist for a large hospital system in the New York Tri-State Area as well as a scientific consultant for Fortune 500 biotechnology firms, healthcare systems throughout the world and R1 Research Level Universities. During his time as a clinical laboratory scientist in his current role, he has improved sample workflow and improved laboratory quality and sample turnaround time while expanding laboratory services to vulnerable health populations in the New York area. He has also provided outreach to the local community by serving as a mentor to students training in clinical laboratory science, as well as the scientific community by serving as a technical resource for his peers in the laboratory.

Through his work as a consultant, he has worked to improve the spread of key technical information in a variety of mediums. Todd has written a number of market research reports used by Fortune 500 biotechnology firms in strategic planning, and led webinars on key quality issues that impact the biotechnology community. He has served R1 Research Level Universities by advising them on strategic technology transfer opportunities, and has been called upon as a key knowledge leader internationally for the biotechnology industry.

Todd Graham graduated in 2006 with a MA in Biology at Queens College (City University of New York) after conducting published research in Molecular Evolution in the laboratory of Dr. Stephane Boissinot. He graduated as a Dean’s List student and James Dickson Carr Scholar from Rutgers University in 2001 with a BS in Biotechnology, where he continues to mentor Biotechnology students. He is a member of the Society for Laboratory Automation and Screening. He is also licensed as a Clinical Laboratory Technologist in New York State and is certified in Molecular Diagnostics by the American Society for Clinical Pathology.

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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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