Automating Assays for Clinical Diagnostics

01:00 PM ET | 10:00 AM PT | 12:00 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"

Steps needed to transfer, validate and maintain an automated assay in the laboratory


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 From new ways to perform assays, to outdated technology, to new equipment pushes to the various needs of end users, assays need to switch between technologies on a regular basis.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. With this seminar, you will be able to fully understand how your assay is currently running and make note of what the new technology should be able to do. Then you will learn how to slowly get the new technology up and running, validating the quality system, equipment and the assay itself. You will learn what you need to understand in the process of transitioning old samples onto the new system and deal with any potential issues. Finally, you will develop a final validation plan that will allow you to embrace the new technology fearlessly. Assays performed by hand have a number of issues that may be assuaged by automation. One problem can be a simple lack of throughput, as a single worker, no matter how skilled, can only do so much work in a day. As technology progresses, there may be a need to automate a procedure so that a given laboratory may remain state-of-the-art. Finally, the automation of procedures may unlock key new capabilities that may enhance productivity in ways that may not be feasible using manual methods. That said, automating laboratory assays from manual methods is rarely as simply as bringing in equipment, programming the assay in and letting it run. A certain level of know-how is needed in order to understand the various pitfalls and issues that come with automating an assay.

With this webinar, you will be able to understand the steps needed to transfer, validate and maintain an automated assay in the laboratory. First, a key understanding of the various steps technicians perform on the bench is necessary, as certain methodologies are difficult to translate onto automation. Then the procedure must be made to work on the automation in a way that is reliable and repeatable. Validation studies must be performed and properly scaled to make sure than the automation works reliably, and that any issues involving the method transfer have been properly resolved. Finally, developing a quality assurance plan in concert with both the assay team and the manufacturer of the automation equipment will be discussed, as quality methods have to adapt to the new technology to maintain proper quality.

Areas Covered

•      What are the individual steps needed to perform the assay on the bench?
•      How will your assay adjust to your automation?
•      What are the pitfalls to look out for during the method transfer process?
•      How scale up the assay validation of an automated system?
•      How to develop and manage the necessary quality procedures with an automated system?
•      How to develop a quality plan to maintain the automated assay?

Who will Benefit

•      Senior management
•      Quality Assurance
•      Research and Development
•      Bench Scientists

Industries who can attend

This 60-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Speaker Profile

Todd Graham

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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