CMC Live - Chemistry, Manufacturing & Controls6 Nov 2020

Halloween Special – Ghosts, Spirits and CMC Regulatory, A Halloween Story

What We Covered

01:12 – Introducing a very spooky Halloween Special where Ed, Brian, Meranda and the rest of the DSI Team share stories of time spent in creepy labs and other scary situations
21:58 – Paul tells a story of working the graveyard shift at a hospital
25:06 – Valerie and Meranda share their own spooky experiences working in pharma
35:01 – An Excel Horror Story
36:06 – Ed shares a scary email story followed by Dave’s liquid ammonia experience
48:55 – Ed, Brian and Meranda thank everyone for joining the show and sharing their stories

Tweetable Quotes

“I’ve never tasted cherries as delicious as the ones that were being fed and rooted from the formaldehyde and sulfuric acid that was being pumped into the soil.”

“You know it’s a bad day when the local news crew is sitting in the lobby when you walk in.”

“I would have to go down and walk – this is in the middle of the night, no one around – walk down to the basement, past the morgue, through the boiler room, into this dark, dank, dusty place with like rats and dig through boxes for the records.”

“I’ve scared myself. I was working late one night and we had liquid oxygen on site and every once in a while you’d get a hiss or a clank or something weird. And the warehouse was making an awful lot of noise one night so I was like, ‘Ok, I’m just gonna go home.’”

“In the days before corporations had things like change control, and quality groups on site and so forth, Smith-Kline and others were organized as just a bunch of chemical operators. And that was it. There was no other functions on site.”

“Dave told a story about liquid ammonia and some scary situation there.”

“I’ve actually been at a place where we did heavy duty analysis on bungie cords.”

Relevant Links

Design Space InPharmatics – LinkedIn

Design Space InPharmatics – Twitter

Edward Narke on LinkedIn

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Episoder(27)

025 - The Parenteral Drug Association & Evolution of Drug Development with Michael Carroll

What We Covered00:55 – Ed, Meranda and Brian welcome today’s guest, Mike Carroll, who speaks to his background in microbiology and product development 04:28 – Mike talks about his involvement in the ...

12 Mar 202131min

024 - Quality Management Systems Explained!

What We Covered00:54 – Ed, Meranda and Brian welcome a special panel of guests to break down today’s topic: Quality Management Systems (QMS) Explained! 07:53 – The panel expounds on the timing necess...

5 Mar 202138min

023 - A Broadway Performance Analogy for API Process Validations with Jim Mencel

What We Covered00:52 – Ed, Meranda and Brian welcome back Jim Mencel who shares his extensive experience with process validation07:46 – The importance of Proven Acceptable Range (PAR) and Critical Pro...

26 Feb 202143min

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

What We Covered00:51 – Ed, Meranda and Brian introduce today’s guest, Shelli Connelly, who discusses her background and speaks to some of the elements of filter validation 05:41 – Shelli talks about ...

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