Dear colleagues, hello! 👋
A special welcome to the 40+ new members who have joined our Let’s Talk Risk! community last 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.
I was recently invited as a guest on a couple of podcasts to talk about the QMSR from a risk management perspective. Listen to these conversations below:
1. With Subhi Saadeh on Combinate Podcast
2. With Monir El Azzouzi on Easy Medical Device Podcast
Announcements
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 March 22, 2024.
LTR monthly webinar series: How to create a master harms list using standard codes
A quick reminder to join me in this month’s webinar, where I will review standardized codes and terms, and provide a step by step example of creating a master harms list for a medical device using public data.
If you are a paid subscriber, you will receive an email with a link to register for this month’s webinar on March 26, 2024 at 11:00 AM EST. You don’t need to pay extra.
If not, you can still attend this webinar with a one time payment of only $25. 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.
LTR weekly conversation on LinkedIn: lessons learned from implementing a QMS in a startup
Join me next Thursday, March 22, 2024 at 11:00 AM EST, for another Let’s Talk Risk! conversation on LinkedIn. My guest this week is Becki Hiebert who will share lessons learned from her personal experience with implementing a QMS in a startup.
Weekly Knowledge Challenge
I hope you enjoyed the knowledge challenge question last week. Here is the correct answer:
The correct answer for the question, “Under the new Quality Management System Regulation (QMSR), due to go into effect in February 2026, FDA may consider a use-error as a type of nonconformity which may require an investigation” is True.
Here is this weeks’ knowledge challenge #25
1-Question Feedback Survey
If you are finding value in reading LTR, please give us a shout out and show your love🙏
LTR Weekly Digest #28 - 16th March, 2024