Online Webinar 2019 - Live Webinar 90 minutes FDA’s Regulation for Molecular Diagnostics

Overview
The FDA process for molecular diagnostics is multifaceted and complex. The FDA gives regulatory discretion to some tests, while mandating strict regulatory approval for other tests. The process can appear contradictory to the outside eye, but there is a logic to this process. This webinar will explain the ins and outs of this process, how to choose the different tracks of the process, and the regulatory requirements for each part of the process. By the end of this webinar, you should be aware of the various options of the process and select which one you should chose to move forward in this process.
Session Highlights
This webinar will help you learn how to navigate the regulatory process. The webinar will include the following critical information you will need:
What is a molecular diagnostic?
What are the different regulatory tracks for molecular diagnostics?
How do companion diagnostic regulations work?
How does laboratory directed testing regulations work?
How does the 510(k) pathway work?
How does the PMA pathway work?
Who will benefit
Bench Scientists
Quality Assurance
Research Scientist
Business Development
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.