TradeStone QA, LLC.

https://www.clinicalleader.com/doc/what-to-expect-from-an-fda-inspection-0001

What To Expect From An FDA Inspection Former FDA inspector turned regulatory consultant, Patrick Stone, gives some valuable insights to what to expect when the FDA comes knocking at your clinical trial site. Here's a hint: make sure you PI knows the difference between presiding over and overseeing a study.

Two of my clients have contracted me for the next few years. Much of my time will be virtually spent working on the day-to day Quality Assurance operations. I had a chance to explain what my job function was at FDA and by default what I am doing now. Thank you for following and keeping up with our Patient Safety endeavors!
How the FDA Conducts a Clinical Trial Inspection: An Interview with me and the Guru Darshan Kulkarni, Pharm. D., M.S., Esquire.

Full Episode: https://lnkd.in/geCFWzP

Google Podcasts: https://lnkd.in/ggXtBEc
Apple Podcasts: https://lnkd.in/eP-kSsp
iHeart Radio: https://lnkd.in/eFMPrzY

How The FDA Conducts A Clinical Trial Inspection: An Interview With Former FDA Inspector Patrick Stone | DarshanTalks Podcast Clinical studies have become increasingly virtual because of COVID-19. How has this affected the way the FDA inspects clinical trials? Join Darshan Kulkarni as he talks with former FDA auditor Patrick Stone about his experience investigating sites and sponsors. Plus, we’ll discuss why virtual moni...

I have had more time to join my collaborators for a few podcasts. Here is one from a few weeks ago on Pharmacy issues. I have not traveled since March and do not plan on flying this year!

Manufacturing Vs Pharmacy: An Interview With Patrick Stone | DarshanTalks Podcast What is an FDA warning letter, and how should your company respond once it has received one? In today's episode, Darshan Kulkarni talks with former FDA inspector Patrick Stone about the auditing process in compounding pharmacies, and how companies should address warning letters issued by the FDA. Pl...