025 - The Parenteral Drug Association & Evolution of Drug Development with Michael Carroll
What We Covered 00:55 – Ed, Meranda and Brian welcome today’s guest, Mike Carroll, who speaks to his background in microbiology and product...
Radio and PodcastLive Radio & Podcasts
Science & Medicine
CMC Live - Chemistry, Manufacturing & Controls
FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulat...
Episodes
20 of 27 episodes
024 - Quality Management Systems Explained!
What We Covered 00:54 – Ed, Meranda and Brian welcome a special panel of guests to break down today’s topic: Quality Management Systems (QMS...
023 - A Broadway Performance Analogy for API Process Validations with Jim Mencel
What We Covered 00:52 – Ed, Meranda and Brian welcome back Jim Mencel who shares his extensive experience with process validation 07:46 – Th...
022 - Filter Validation & How It Impacts Getting Your Product to Market with Shelli Connelly
What We Covered 00:51 – Ed, Meranda and Brian introduce today’s guest, Shelli Connelly, who discusses her background and speaks to some of t...
021 - Regulatory Odd Couple with Ed Narke & Meranda Parascandola
What We Covered 00:51 – Meranda and Ed discuss the Regulatory Odd Couple blog series and constructing the CTD Module 3 11:54 – Ed explains t...
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 ext...
019 - Complexity of Project Management in Drug Development with Paul Long
What We Covered 00:55 – Ed, Brian and Meranda welcome to the show Paul Long who shares his well-rounded background as a project management c...
018 - 2020: A Year in Review with Ed Narke, Brian Lihou & Meranda Parascandola
What We Covered 00:43 – Ed, Brian and Meranda introduce today’s 2020 Year-In-Review show and look back on learnings from Jim Mencel, Dave Ad...
017 - 4 Experts, 120+ Years of Drug Substance Experience: Major Trends You Should Know
What We Covered 01:03 – Ed, Brian and Meranda welcome to the show a panel of drug substance services experts, Daniel Torok, Dave Adams, Jim...
016 - Brexit: What You Need to Know for Drug Development
What We Covered 00:54 – Ed, Brian and Meranda welcome to the show Amber Sheriff who speaks to her background as a regulatory affairs special...
015 - Outsourcing in China: How far can it go?
What We Covered 00:55 – Ed, Brian and Meranda welcome to the show David Blasingame who speaks to his extensive background as a process chemi...
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 t...
014 - Why now is the most important time for selecting a CMO
What We Covered 01:19 – Ed, Brian and Meranda welcome to the show Dr. Rick Offerman who speaks to his experience as a process chemist, the d...
013 - A Discussion on CMC Strategy and Submissions with Ed Narke, Brian Lihou & Meranda Parascandola
What We Covered 01:16 – Ed, Brian and Meranda take a deep dive into analyzing CMC strategy and submissions 11:26 – Ed, Brian and Meranda dis...
012 - Taking Medicines Back to The Future – A Discussion with Hedley Rees on Value Chain vs. Supply Chain: What's the Difference?
What We Covered 00:59 – Hedley Rees joins the show to share his background in the pharmaceutical industry, his thoughts on Big Pharma and is...
011 - Hey Google, tell me about the importance of living Development Reports with Kyriakos Michailaros
What We Covered 00:53 – Kyriakos Michailaros joins the show to share his background and expertise in the subject matter of drug product serv...
010 The White Coat Effect is Real – The Role of Person in Plant Discussion - Daniel Torok
What We Covered 00:46 – Daniel Torok joins the show to share his experience as a process chemist and collaborating with CMOs in the pharmace...
009 Recipes to Build Towards Your NDA/BLA - Ed Narke, Brian Lihou and Meranda Parascandola
What We Covered 00:44 – Ed, Brian and Meranda join the show to share their experiences in all phases of the pharmaceutical development indus...
008 Trust the Process with a CMC Process Champion - Dave Adams
What We Covered 01:15 – Dave Adams joins the show to discuss his experience with active pharmaceutical ingredients (APIs) and provides examp...
007 Selecting a Contract Manufacturing Organization (CMO) - ‘Super’ Les Mintzmyer
What We Covered 01:32 – Les Mintzmyer joins the show to discuss his background in biologics manufacturing, speak to CMO selection, and break...