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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...
What We Covered 00:55 – Ed, Meranda and Brian welcome today’s guest, Mike Carroll, who speaks to his background in microbiology and product...
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...
What We Covered 00:52 – Ed, Meranda and Brian welcome back Jim Mencel who shares his extensive experience with process validation 07:46 – Th...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
What We Covered 00:53 – Kyriakos Michailaros joins the show to share his background and expertise in the subject matter of drug product serv...
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...
What We Covered 00:44 – Ed, Brian and Meranda join the show to share their experiences in all phases of the pharmaceutical development indus...
What We Covered 01:15 – Dave Adams joins the show to discuss his experience with active pharmaceutical ingredients (APIs) and provides examp...
What We Covered 01:32 – Les Mintzmyer joins the show to discuss his background in biologics manufacturing, speak to CMO selection, and break...
What We Covered 00:43 – Colman Byrne joins the show to discuss his background in analytical chemistry and challenges he’s observed in analyt...
What We Covered 03:00 – Dr. Catherine Bernard joins the show to discuss her background in regulatory affairs within the pharmaceutical indus...
What We Covered 02:08 – Bettina Kaplan joins the show to discuss her background in quality assurance, compliance and auditing within the pha...
What We Covered 02:10 – Judy Magruder joins the show to discuss her background in early stage drug development and best practices for creati...
What We Covered 00:54 – James continues his discussion of expedited drug development programs, focusing on the importance of establishing re...
What We Covered 00:23 – James discusses regulations and the importance of starting with big ideas when it comes to expedited drug developmen...
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