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FATALITY MANAGEMENT TOOLKIT Adph  Form

FATALITY MANAGEMENT TOOLKIT Adph Form

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[Music] today we're going to talk about a pre-submission master class we um you guys probably all know me by now but I've been in reqa for over 20 years I've assisted more than 150 companies but I've also been on the FDA good manufacturing practices advisory committee I served a term as the industry representative there this is my executive team um so today we're going to go through a crash course in Pre submissions um we are going to also cover different types of Q submissions like the 513g the Breakthrough device request the safer Technologies program and Lessons Learned and hopefully at the end of the course you'll be able to differentiate between them and what's the best to use for your purpose so let's get started with prese submissions so prese submissions can be a really powerful tool um and the opportunity to ask very specific questions um of the FDA and make the FDA really a more of a partner to you than an advers

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