Bio: With over 2 decades of experience in animal husbandry, food safety, nutraceutical, pre-clinical, and pharmaceutical industries I am pleased to share my experience with FDA regulations and how it impacts daily molecular testing and recordkeeping.
You Bet Your Assay-How Confident Are You With Your Process Controls?
Presented at:
The Thomas Experts Series & The Thomas Center Labs
Speakers
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Bradley Bellows
Bio: Marketing and visual communication have been my passion in a career that has spanned over two decades. My professional goal is to facilitate advertising and public relations strategies geared towards achieving my company's objectives.
Abstract
The FDA submitted its final rule regarding laboratory diagnostic tests (LDTs) on May 6, 2024. While it allows for 4 years for compliance and it is currently being disputed by various associations that deal directly in LDTs, how will this affect you? We will discuss the basics of the ruling, how you can address the upcoming changes, and how Varizymes can help you with one of the basic forms of compliance that comes with increased scrutiny about how your assays are built, validated, and verified to protect Point of Care end users.
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