46 2014 - How to Develop Quality Systems for New Diagnostic Assays

Instructor: Todd Graham
Description:
This 1-hr virtual seminar will help you understand the the necessary steps of develop a quality system for a new diagnostic assay that will comply with Good Laboratory Practices and Good Manufacturing Practices in the United States. The resulting quality system will support the develop of an assay for diagnostic use that can be approved through either the 510(k) process or the Pre-Market Application (PMA) process.
Why Should you Attend:
It’s one thing to have good quality research and intellectual property that can fit an unmet need in the diagnostic marketplace. It’s quite another to turn it into an actual product. If a discovery cannot be turned into a useable product, then that knowledge cannot be used to improve human health. With this seminar, you will be able to identify the steps you need to take in order to develop a quality system for a diagnostic assay. You’ll be able to learn the breadth and depth a quality system needs to have, as well as the potential pitfalls to look out for. Also, with different types of reagents, you will learn how to develop standards for the assay to insure the robustness of the assay and to allow for any potential problems with the assay to be easily observed.
Objectives of the Presentation:
This webinar will help you identify the key steps needed to take in order to develop a quality system for a new assay. This will allow you to expedite the process of an assay getting from research to clinical trials. The webinar will include the following critical information you will need:
What information is needed to perform and validate the assay
Identifying the necessary reagents and the quality testing needed for each reagent
Identifying the documentation needed to maintain quality from both internal and external sources
Training laboratory personnel on how to document quality control for the reagents and the assay
Developing the proper controls for a given assay and performing quality control on the assays
Tying together all the documentation for a fully-controlled assay to go into clinical trials
Who can Benefit:
This topic applies to personnel / companies in the medical diagnostic industry. The employees who will benefit most include:
Senior management
Quality Assurance
Research and Development
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