Assay Validation for Clinical Diagnostics

Instructor: Todd Graham
Product ID: 702872
Training Level: Basic to Intermediate
  • 19
  • December 2018
    Wednesday
  • 10:00 AM PST | 01:00 PM EST
    Duration: 60 Min
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.

Live Online Training
December 19, Wednesday 10:00 AM PST | 01:00 PM EST | Duration: 60 Min

$199.00
One Dial-in One Attendee
$529.00
Group-Max. 10 Attendees/Location
(For Multiple Locations Contact Customer Care)
Super Deal - Get CD/USB Drive Free!

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD / USB Drive

$349.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$349.00

Live + Training CD/USB

$449.00

Customer Care

Fax: +1-650-362-2367

Email: customercare@complianceonline.com

Read Frequently Asked Questions

Why Should You Attend:

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 From new ways to perform assays, to outdated technology, to new equipment pushes to the various needs of end users, assays need to switch between technologies on a regular basis.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.

  • how your assay is currently running and make note of what the new technology should be able to do.
  • how to slowly get the new technology up and running, validating the quality system, equipment and the assay itself.
  • 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. 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:

  • What are the key differences between a research assay and a clinical assay?
  • How to make sure an assay can regularly be performed by a medical technologist, and how to validate those changes?
  • How do you find clinical relevant samples to test your assay against?
  • How to find a Gold Standard assay and develop a validation plan against it?
  • How to validate an assay for clinical use?
  • How to develop a clinical quality plan to make sure the assay remains valid?

Who Will Benefit:

This topic applies to personnel/ companies in the biotechnology and pharmaceutical industry. The employees who will benefit most include:

  • Senior management
  • Quality Assurance
  • Research and Development
  • Medical Technologists
  • Scientists
  • R&D
  • Regulatory Affairs
  • Validation Specialists
  • All personnel who perform, supervise, manage, audit, or oversee the validation of assays in a laboratory
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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Refund Policy

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.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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