How to Develop Quality Systems for New Diagnostic Assays

Duration: 60 Minutes
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.
Good Manufacturing Practices
Instructor: Todd Graham
Product ID: 500246

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
$375
Recorded Session for one participant
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Minimum 10 attendees
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  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
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Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Todd Graham is a masters-level bench scientist and medical technologist with a host of experience in both clinical diagnostics and biotechnology fields. He has worked 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 expertise are in molecular diagnostics, PCR, ELISA, quality control and training of bench level personnel in clinical diagnostics and biotechnology. He has established a consultancy to assists academic labs in transitioning their research to industry by verifying and improving the quality of their work.


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