RAQA Today
Michelle LottPodcast by Michelle Lott
| Publishes | Weekly | Episodes | 44 | Founded | 3 years ago |
|---|---|---|---|---|---|
| Number of Listeners | Category | Business | |||
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Latest Episodes
The good folks at Vistatec invited me to participate in their Life Science In-Focus podcast last month, where host Karen Tkaczyk and I chatted about the intricacies of regulatory affairs within the life sciences. We also discussed just how I ended up... more
This is not last year's eSTAR - a LOT has changed, and there are things you need to know before you try to submit your 510k. In this episode, we'll guide you through the intricacies of the latest eSTAR 5.0 platform, crucial for those of you planning ... more
Why would you use a 3rd party reviewer for your submission? How does a 3rd party reviewer function? How is it different from working with the FDA? I sat down with my good friend Shawnnah Monterrey from Beanstock Ventures to answer all your pressing q... more
Question, questions, everyone has questions about eSTAR 5.0, so I sat down with the FDA's Patrick Axtell to answer the most pressing ones I've received. From file size to eSTAR type to biocompatibility - we cover it all.
When is it better for a medtech startup to hire a fractional quality professional, and when is it time to hire full-time? This is not necessarily an easy question to answer, and there can be a lot of factors impacting the decision. In this joint podc... more
As medical devices become more connected, concerns about security increase, leaving manufacturers - and regulatory staff - uncertain as to the best path forward. Listen in as Michelle and guest Randy Horton discuss industry needs and what the FDA pla... more
Many manufacturers see quality as a necessary evil, a box to be checked just to placate the FDA on the way to market launch. But it can be SO much more. In this episode, Ti Benson and I discuss how quality can actually be a business benefit and not s... more
You may think document control is boring, but wait until you hear these stories: Red-lined post-it notes. Uncontrolled copies passed around during inspections. Master files stored on a desktop instead of in the eQMS system. Secret file cabinets in lo... more
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| Listeners per Episode | Gender Skew | Engagement Score | |||
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| Primary Location | Social Media Reach | ||||
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RAQA Today launched 3 years ago and published 44 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.
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