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

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

What We Covered
  • 00:54 – Meranda and Brian flip the script by introducing fellow host, Ed Narke as today’s guest
  • 01:56 – Ed speaks to his extensive background in CMC and the importance he places on building relationships based on trust
  • 11:06 – Ed expounds on his role at DSI and the impact he, Brian, Meranda and the entire DSI team are having on the CMC industry
  • 17:11 – Ed talks about his personal background and roots and the value of being adaptable and the impact COVID-19 has had on his business
  • 21:36 – Ed thanks some of the many mentors and friends who have assisted him throughout his career
  • 26:48 – Ed provides best practices and advice for operating within the CMC industry
  • 30:55 – How Ed strives to build trust in relationships
  • 37:27 – Ed shares some of his thoughts on the keys to his success
  • 40:32 – Ed answers a listener question about microbiome-based products
  • 43:31 – The value of developing powerful, positive routines
  • 45:46 – Understanding the urgency of self-improvement
Tweetable Quotes

“I look back on my career and I kind of made a few big mistakes. For example, I went into the office of the Vice President at this company to resign. I was a kid and I was just upset about certain stupid little things. And, when I walked in there, instead of leaving the job, I made a connection with him as another lifelong mentor.”

“Comparing INDs, NDAs, BLAs, I’ve always had this fascination with putting stuff together into a story.”

“I hope I look back in fourteen years and say, ‘These are the best days of my life.’”

“One of the things I have to remind myself every day is that life really hasn’t changed, I have.”

“Everything I learned that is valuable and dicey and on the edge I learned from Dan [Torok].”

“My goal, hopefully, is to grow CMC Live, make it more interactive and maybe have a live audience with questions.”

“To truly build trust, I learned it’s better for my colleagues to get to know me as a person.”

“Two things control the way we operate and who we are: our brains and our gut.”

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

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!

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

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

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

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

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

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

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

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