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 Maalis 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 Maalis 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 Helmi 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 Helmi 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 Helmi 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 Tammi 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 Tammi 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 Tammi 202152min
