After The Warning Letter with FDA Attorney Amanda Johnston.

12/28/21 • 23 min

Warning Letters are more than a slap on the wrist. They are the first step in what can be a costly remediation and legal battle.
How do we prevent them? What is within the power of the FDA and government when they spot quality issues? To help us with these questions and more, we are joined by Amanda Johnston of Gardner Law. Amanda has over a decade of experience in FDA Regulatory Law and experience with all sizes of companies.
To learn more about Gardener Law, check out their website: https://gardner.law/

Previous Episode

Intermission: Shannon Van Buskirk --SD Bio Member Relations Specialist

On this intermission, we meet Shannon Van Buskirk. She recently joined SD Bio to provide extra support for members and is jumping into our community. She brings a background in pharmaceutical sales, talent on the piano, and a passion for meeting new people. If you haven't met her yet, you definitely should!
p.s. we recorded this the week before Thanksgiving, and I showed up wearing a turkey hat for the interview.

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Inside Out Quality - After The Warning Letter with FDA Attorney Amanda Johnston.

Transcript

Aaron Harmon00:00:00.000

Hi, I'm Aaron Harman and this is inside out quality, a podcast about real life events and experiences shared by our guests of when things have gone wrong, and how we can learn from them to build better products, companies and improve lives through an effective quality system. FDA warning letters, quality nerds love to read these. It's like the obituary section of the newspaper for quality assurance. And why do we care so much? I have two reaso