Dear colleagues, hello! 👋
A special welcome to the 170+ new members who joined our Let’s Talk Risk! community in April! Feel free to browse past articles in the archive section of the Let’s Talk Risk! website, and check out recordings of recent LTR conversations in the podcast section.
Here are links to articles published this week.
Announcements
LTR weekly conversation on LinkedIn: FDA’s pre-submission program
Join me next Friday, May 10, 2024 at 11:00 AM EST, for another Let’s Talk Risk! conversation on LinkedIn. My guest is Amit Guruprasad, who will share how we can benefit from FDA’s pre-submission program to accelerate new product development and regulatory approval.
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Weekly Knowledge Challenge
I hope you enjoyed the knowledge challenge question last week. Here is the correct answer:
The correct answer for the question, “In recent months, you have seen a sharp increase in number of adverse events that can be traced back to a safety-critical component sourced from a supplier. Which of the following is the best action to remain compliant with ISO 13485?” is Initiate Supplier Corrective Action.
Here is this weeks’ knowledge challenge #32
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