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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This is an on-demand recording from March 2022.
Recently, FDA released two draft guidance documents outlining the transition plan for devices granted an Emergency Use Authorization under the Covid-19 Pandemic to fully legally cleared products. Many of the recommendations in these guidances leave industry professionals without a clear understanding of what FDA is trying to accomplish with the process.
This live webcast will review FDA's proposed recommendations for devices with EUAs, recommended feedback manufacturers and regulatory professionals should provide to FDA prior to guidance finalization, and next steps to anticipate for products with an active EUA.
By attending this program, you will:
- Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Any company that currently holds an Emergency Use Authorization and intends to transition the products to legally marketed devices.
Michelle Lott, Principal & Founder
Michelle Lott is founder and principal of leanRAQA. She has supported more than 100 companies with regulatory strategy, regulatory submissions, quality systems compliance, due diligence and technical support services. Lott’s clients delegate these things to her so they can focus on winning in the marketplace. She served a four-year term on the US Food and Drug Administration (FDA) Device Good Manufacturing Practices Advisory Committee (DGMP), and she has completed the RAPS Executive Development Program at the Kellogg School of Management at Northwestern University.
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
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