TradeStone QA, LLC.

04/29/2024

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

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.

12/28/2021

https://www.youtube.com/watch?v=jFlPOesedfI&t=3s Here is our last New Year podcast The year of light 2022!

Pat's book: https://www.amazon.com/Bubble-Gum-Badge-Fda-His-Story-ebook/dp/B0793TJBS9/ref=sr_1_1?crid=3VF50BIQCHUTH&keywords=bubble+gum+badge+book&qid=164071...

12/03/2021

I hope you are all having a good Christmas season! I have done it again. This pod cast is revealing and maybe controversial to some. Guru Dan asked me about vaccines and the jab so here we are.

Pat’s LinkedIn: https://www.linkedin.com/in/patrickstone1Join this channel to get access to perks:https://www.youtube.com/channel/UCvw9kVKHEyAlZPZ6ZuOd2VA/jo...

10/29/2021

In September, I closed out the year long project with our last direct pharma client. We just signed another long term project with another infectious disease client (direct pharma) that will keep the lights on until at least next August. This new client started off with pre-approval work for the manufacturing and ended up with both good clinical practice & the manufacturing part. This will be a remote job but the team in Boston will want a few face to face meetings. I hope you all have a safe & fun spooky weekend and thank you for following.

06/11/2021

My current project had expanded since last August. My Boss was grooming me for a permanent role in the organization. I would have been able to speak about the products I am working on and buy stock for the first time! As with all thing change is constant and the Boss is now leaving next week. The new team is not looking to hire the old guard. TradeStone QA lives on and we will be transitioning in Dec to a new area of the current organization or on to new clients altogether. It has been a great run going on a year and the patient safety endeavors continue! I will now have more time to go on vacation and have a real summer with my beautiful growing family! I hope you all have a great and HOT summer!

05/08/2021

I was interviewed by ABC for the mRNA jab issues encountered by J&J product manufacturing hold.

“VACCINE WATCH: examines the history of FDA citations for Emergent BioSolutions, which was forced to pause new production of a key ingredient for Johnson & Johnson’s COVID vaccine. https://t.co/89rGo4QEuG https://t.co/uKSrWQa0Xx”

05/01/2021

The past 10 years has gone by at warp speed and has not slowed down. What a milestone to be in biz for a decade! This past year I have been blessed to be home 100% of the time. We have landed the biggest client to date with a contract for 2022 through to 2023 if everything goes according to plan. In this business it is unusual for everything to go according to a plan. Thank you for following and supporting us as we continue this journey of patients safety and effective healthcare for all. We are on the job for your health and wellness!

12/05/2020

This past Thursday TradeStone QA was part of a drug candidate nomination for a first of kind new class of treatment. I am being vague on purpose but it has been 50 years since the last time this happened (I am almost 50). I did not realize the significance until I thought about the past 9 years and 9 months of business. As part of a team located in Oxford UK & Boston, our goals are patient safety & effective healthcare for the global market place. Thank you all for following and have a blessed Holidays season. This is epic news and to share it now at the end of this very tough year is also a blessing!

11/12/2020

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

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...

09/16/2020

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!

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...

07/24/2020

I had the opportunity to speak with a Pharm. D., Lawyer, Inventor, and Engineer for top tier Healthcare innovators. My part start at 6:03 minutes. I provide what type of work I am doing now and how I assist my clients make it to the US market. Stay safe and dry out there we have a storm (Hanna) coming our way. Thank you for following.

Auditing, and Augmenting Options: An Interview With Former Auditor Patrick Stone Episode post: https://darshantalks....

07/10/2020

It has been too long since I updated you on what I am doing currently. Here is a YouTube of what I am doing. Thank you for following. https://www.youtube.com/watch?v=U8zdZoS0dao&feature=youtu.be
Business is booming through this difficult time in our worlds history. Now it is all remote with no travel.

Former FDA Auditor and Sponsor Consultant Talks Clinical Research Audits, PI and CRA Oversight Pat's LinkedIn: https://www.linkedin.com/in/patrickstone1/ Tex...