CMC Live - Chemistry, Manufacturing & Controls2 Okt 2020

010 The White Coat Effect is Real – The Role of Person in Plant Discussion - Daniel Torok

What We Covered

00:46 – Daniel Torok joins the show to share his experience as a process chemist and collaborating with CMOs in the pharmaceutical industry
07:54 – Daniel speaks to the importance of building trust in order to become an effective in-plant person
19:59 – Daniel details best practices he utilizes for site visits
24:15 – The information exchanged in a well-rounded site wrap up report
28:47 – Daniel shares some facts, myths and stories about CMOs
37:47 – Ed, Brian and Meranda thank Daniel for joining the show

Tweetable Quotes

“The White Coat Effect is real. Even in a good facility it’s absolutely real. When operators find out the client is coming they behave very differently and the level of detail is much more.”

“Probably the most touching was I spent a lot of time on an API facility on the East Coast and, on the last day, their process chemist said, ‘I want to thank you. You’re the first person in plant who’s ever actually helped me.”

“I warn them, ‘I’m gonna be there when you don’t really want me there.’”

“Just because you walk out the door of the plant and you go to the airport and get on the plane, it [the process] shouldn’t be done or finished for us.”

“I think one of the myths people have is that a CMO absolutely knows their equipment all the time and the process is going to be run the same every single time.”

“It changes, it’s going to be fluid in this industry. Things happen. Things go wrong.”

Relevant Links

Design Space InPharmatics - LinkedIn

Design Space InPharmatics - Twitter

Daniel Torok on LinkedIn

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Episoder(27)

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024 - Quality Management Systems Explained!

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022 - Filter Validation & How It Impacts Getting Your Product to Market with Shelli Connelly

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19 Feb 202132min

021 - Regulatory Odd Couple with Ed Narke & Meranda Parascandola

What We Covered00:51 – Meranda and Ed discuss the Regulatory Odd Couple blog series and constructing the CTD Module 3 11:54 – Ed explains the importance of building the Quality Overall Summary (QOS) ...

12 Feb 20211h

020 - Lessons Gleaned from Twenty Five Years of a Regulatory CMC Life with Ed Narke

What We Covered00:54 – Meranda and Brian flip the script by introducing fellow host, Ed Narke as today’s guest01:56 – Ed speaks to his extensive background in CMC and the importance he places on build...

29 Jan 202148min

019 - Complexity of Project Management in Drug Development with Paul Long

What We Covered00:55 – Ed, Brian and Meranda welcome to the show Paul Long who shares his well-rounded background as a project management consultant and speaks to some of the benefits and challenges o...

22 Jan 202143min

018 - 2020: A Year in Review with Ed Narke, Brian Lihou & Meranda Parascandola

What We Covered00:43 – Ed, Brian and Meranda introduce today’s 2020 Year-In-Review show and look back on learnings from Jim Mencel, Dave Adams and Daniel Torok10:11 – Ed, Brian and Meranda reflect bac...

8 Jan 202152min