Assay Validation for Clinical Diagnostics

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 From new ways to perform assays, to outdated technology, to new equipment pushes to the various needs of end users, assays need to switch between technologies on a regular basis.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