CMC Live - Chemistry, Manufacturing & Controls

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

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

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 Acceptabl

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 validatio

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

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

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

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,

017 - 4 Experts, 120+ Years of Drug Substance Experience: Major Trends You Should Know

What We Covered01:03 – Ed, Brian and Meranda welcome to the show a panel of drug substance services experts, Daniel Torok, Dave Adams, Jim Mencel and David Blasingame who

016 - Brexit: What You Need to Know for Drug Development

What We Covered00:54 – Ed, Brian and Meranda welcome to the show Amber Sheriff who speaks to her background as a regulatory affairs specialist in the pharmaceutical indus

015 - Outsourcing in China: How far can it go?

What We Covered00:55 – Ed, Brian and Meranda welcome to the show David Blasingame who speaks to his extensive background as a process chemist as well as the advantages an

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

What We Covered01:12 – 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 ot

014 - Why now is the most important time for selecting a CMO

What We Covered01:19 – Ed, Brian and Meranda welcome to the show Dr. Rick Offerman who speaks to his experience as a process chemist, the drug development process and wha

013 - A Discussion on CMC Strategy and Submissions with Ed Narke, Brian Lihou & Meranda Parascandola

What We Covered01:16 – Ed, Brian and Meranda take a deep dive into analyzing CMC strategy and submissions11:26 – Ed, Brian and Meranda discuss resources required for comp

012 - Taking Medicines Back to The Future – A Discussion with Hedley Rees on Value Chain vs. Supply Chain: What's the Difference?

What We Covered00:59 – Hedley Rees joins the show to share his background in the pharmaceutical industry, his thoughts on Big Pharma and issues he’s observed with medicin

011 - Hey Google, tell me about the importance of living Development Reports with Kyriakos Michailaros

What We Covered00:53 – Kyriakos Michailaros joins the show to share his background and expertise in the subject matter of drug product services 02:59 – Kyriakos shares hi

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

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

009 Recipes to Build Towards Your NDA/BLA - Ed Narke, Brian Lihou and Meranda Parascandola

What We Covered00:44 – Ed, Brian and Meranda join the show to share their experiences in all phases of the pharmaceutical development industry5:12 – The process of filing

008 Trust the Process with a CMC Process Champion - Dave Adams

What We Covered01:15 – Dave Adams joins the show to discuss his experience with active pharmaceutical ingredients (APIs) and provides examples of how he’s solved problems

007 Selecting a Contract Manufacturing Organization (CMO) - ‘Super’ Les Mintzmyer

What We Covered01:32 – Les Mintzmyer joins the show to discuss his background in biologics manufacturing, speak to CMO selection, and break down the RFP process 08:14 – L