Analyzing Assay Validation for Clinical Diagnostics
Duration : 60 Minutes
Todd Graham,
Todd Graham , is a masters-level bench scientist and medical technologist with a host of experience in both the clinical diagnostics and biotechnology fields. He has work for a number of start-up firms in the clinical diagnostics and biotechnology industries, as well as worked for larger firms within both industries. He has a Read more
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.
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.
Course Objective:
In this 60-minute training, you will 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.
Course Outline:
• 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?
What You Get:
• Training Materials
• Live Q&A Session with the Speaker
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
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
• Medical Technologists
• Scientists
• Regulatory Affairs
• Validation Specialists
• All personnel who perform, supervise, manage, audit, or oversee the validation of assays in a laboratory
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
