ComplianceOnline

Assay Validation for Clinical Diagnostics

Instructor: Todd Graham
Product ID: 702872
Training Level: Basic to Intermediate
  • Duration: 60 Min

recorded version

$229.00
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

Training CD

$299.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

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.

Why Should You Attend:

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.

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.

Area Covered in this Webinar:

This webinar will help you learn how to validate assays for clinical diagnostics. The webinar will include the following critical information you will need:

  1. What are the key differences between a research assay and a clinical assay?
  2. How to make sure an assay can regularly be performed by a medical technologist, and how to validate those changes?
  3. How do you find clinical relevant samples to test your assay against?
  4. How to find a Gold Standard assay and develop a validation plan against it?
  5. How to validate an assay for clinical use?
  6. 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, 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 broad level of expertise in assay development for quality control, pharmaceutical development and clinical diagnostics. His particular levels of expertises are molecular diagnostics, PCR, ELISA, quality control and training of bench level personnel in clinical diagnostics and biotechnology. He is also in the process of establishing a consultancy that assists academic labs in transitioning their research to industry by verifying and improving the quality of their work.

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