This training on assay validation will teach you how to validate an assay for clinical diagnostics and transition the assay into the clinical laboratory for diagnostic use.
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. Laboratories need to transition technologies all of the time. From new ways to perform assays, to outdated technology, to new equipment pushes to the various needs of end users, assays need to switch between technologies on a regular basis. One needs to be able to easily and robustly transition assays from one technology to another.
Finally, you will develop a final validation plan that will allow you to embrace the new technology fearlessly. On a regular basis, there are assays that get developed that have a clear utility in the clinic. However, what may be practical within a research context may not be practical within a clinical context.
In addition, these assays have to be able to handle clinically relevant samples, which often differ from the samples used in research studies. Unless an assay can give clinically actionable results in a clinical laboratory, whatever utility the assay may have will be useless to clinical practioners, who have different demands than research laboratories. By the time you are finished with this seminar, you will be able to learn what needs to be done to an assay to make sure it is ready for the clinic and how to validate such changes.
In addition, you will learn how to select a clinically relevant population for a given assay, validate the assay within such a population and how to select Gold Standards for comparison. Finally, you will be able to develop clinical quality monitoring standards to make sure the assay remains relevant in a clinical context.Learning Objectives:
This webinar will help you learn how to validate assays for clinical diagnostics. The webinar will include the following critical information you will need:
This topic applies to personnel/ companies in the biotechnology and pharmaceutical industry. The employees who will benefit most include:
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.
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. FDATrainingAlert 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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