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

EPISODE · Oct 2, 2020 · 39 MIN

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

from CMC Live - Chemistry, Manufacturing & Controls · host Ed Narke, Daniel Torok, Meranda Parascandola

What We Covered00:46 – 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 LinksDesign Space InPharmatics - LinkedInDesign Space InPharmatics - TwitterDaniel Torok on LinkedIn

Daniel Torok is a Senior Drug Substance Consultant at Design Space InPharmatics. With a background as a process chemist and years of experience in process development and API Operations, Daniel brings a unique perspective on CMC and the pharmaceutical industry. Today, Daniel discusses the vital role that trust plays in the relationship between a sponsor company and a contract manufacturing organization (CMO) as a Person In-Plant. He provides real-world examples of Person in-plant visits he’s conducted. Finally, he lists some interesting facts, myths and stories about CMOs.

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

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This episode was published on October 2, 2020.

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What We Covered00:46 – 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...

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