Playback speed
×
Share post
Share post at current time
0:00
/
0:00
Transcript

LTR Weekly Digest #32 - 13th April, 2024

Catch up on this week's articles - Question about benefit-risk analysis, tips for boosting effectiveness of post-market surveillance, and focusing on quality culture for success in FDA inspections.

Dear colleagues, hello! 👋

A special welcome to the 45 new members who have joined our Let’s Talk Risk! community this week! 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 monthly webinar series: Case study discussion and general Q&A

A quick reminder to join me in this month’s webinar, where I will review a case study based on a recent FDA warning letter citing issues with risk estimation. We will also have a general Q&A session on your risk management question.

If you are a paid subscriber, you will receive an email with a link to register for this month’s webinar on April 23, 2024 at 11:00 AM EST. You don’t need to pay extra.

If not, you can upgrade your subscription, or pay a one time payment of only $25 to attend this specific webinar. Click the link below to make a payment and secure your spot. Once you complete the payment, you will receive the registration link by email.

Register now to attend (Only $25)


Special promotional offer

Register for a fully on-demand ISO 14971 certification course and get 6 months of complimentary access to premium content on Let’s Talk Risk! (a $120 value!).

Watch a course introduction video and check out testimonials from past attendees!

Note: This offer expires on April 19th, 2024.

Get Certified Now


LTR weekly conversation on LinkedIn: A new paradigm for managing risk in the age of AI

Join me next Friday, April 19, 2024 at 11:00 AM EST, for another Let’s Talk Risk! conversation on LinkedIn. My guest this week is Marco Felsberger, who will share why we must start focusing on building resilience to manage uncertainty in our rapidly changing world. This is particularly relevant as AI, and GenAI continues to evolve rapidly, especially in healthcare applications.

Join the Conversation


Weekly Knowledge Challenge

I hope you enjoyed the knowledge challenge question last week. Here is the correct answer:

The correct answer for the question, “A hazardous situation may occur when there is no device malfunction” is True.

Here is this weeks’ knowledge challenge #29

Loading...

1-Question Feedback Survey

Loading...

Want to share feedback? Send a message to me!


If you are finding value in LTR, please give us a shout out and show your love🙏

Share your experience!

Discussion about this podcast