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 regulatory CMC matters. We will focus on the critical CMC issues and build programs that enhance drug development. CMC topics will include Regulatory Starting Materials, API and Drug Product Process, Formulation Development, Supply Chains, Analytical Controls. Advocating and interpreting CMC Strategy, directing CMC Operations and Quality Assurance oversight in conjunction with developing CMC submission content that represents the best interests of emerging biotech. NOT INTENDED TO BE PRESCRIPTIVE ADVICE BUT RATHER INTERPRETATION THAT IS RIGHT FOR YOU. Since 2007 we have provided our partners with innovative strategies and exceptional advice intended to enhance program development, product approval, and marketing presence.
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025 - The Parenteral Drug Association & Evolution of Drug Development with Michael Carroll (00:31:51)
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 ...
024 - Quality Management Systems Explained! (00:38:59)
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...
023 - A Broadway Performance Analogy for API Process Validations with Jim Mencel (00:43:53)
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...
022 - Filter Validation & How It Impacts Getting Your Product to Market with Shelli Connelly (00:32:10)
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 ...
021 - Regulatory Odd Couple with Ed Narke & Meranda Parascandola (01:00:18)
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) ...
020 - Lessons Gleaned from Twenty Five Years of a Regulatory CMC Life with Ed Narke (00:48:13)
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...
019 - Complexity of Project Management in Drug Development with Paul Long (00:43:17)
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...
018 - 2020: A Year in Review with Ed Narke, Brian Lihou & Meranda Parascandola (00:52:38)
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...
017 - 4 Experts, 120+ Years of Drug Substance Experience: Major Trends You Should Know (00:34:30)
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 speak to trends they’ve obser...
016 - Brexit: What You Need to Know for Drug Development (00:32:41)
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 industry and the three procedures f...
015 - Outsourcing in China: How far can it go? (00:33:40)
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 and disadvantages of manufacturi...
Halloween Special – Ghosts, Spirits and CMC Regulatory, A Halloween Story (00:49:53)
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 other scary situations21:58 – Pa...
014 - Why now is the most important time for selecting a CMO (00:48:01)
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 what goes into selecting a solven...
013 - A Discussion on CMC Strategy and Submissions with Ed Narke, Brian Lihou & Meranda Parascandola (00:41:57)
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 compiling CMC dossiers and the imp...
012 - Taking Medicines Back to The Future – A Discussion with Hedley Rees on Value Chain vs. Supply Chain: What's the Difference? (00:44:38)
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 medicine coming to market09:43 – Hedl...
011 - Hey Google, tell me about the importance of living Development Reports with Kyriakos Michailaros (00:41:49)
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 his thoughts on appropriate timi...
010 The White Coat Effect is Real – The Role of Person in Plant Discussion - Daniel Torok (00:39:40)
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 speaks to the importance of bu...
009 Recipes to Build Towards Your NDA/BLA - Ed Narke, Brian Lihou and Meranda Parascandola (00:50:50)
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 an Investigational New Drug (...
008 Trust the Process with a CMC Process Champion - Dave Adams (00:49:26)
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 with APIs in the past09:41 – ...
007 Selecting a Contract Manufacturing Organization (CMO) - ‘Super’ Les Mintzmyer (00:45:49)
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 – Les speaks to the criteria he u...
006 Analytical Method Development - Colman Byrne (00:50:05)
What We Covered00:43 – Colman Byrne joins the show to discuss his background in analytical chemistry and challenges he’s observed in analytical method development and validation10:27 – Colman’s recomm...
005 Pharmaceutical Regulations in CMC - Dr. Catherine Bernard (00:35:21)
What We Covered03:00 – Dr. Catherine Bernard joins the show to discuss her background in regulatory affairs within the pharmaceutical industry07:35 – Dr. Catherine speaks to some of the challenges ass...
004 Quality Assurance and Auditing in the Age of Covid-19 - Bettina Kaplan (00:33:15)
What We Covered02:08 – Bettina Kaplan joins the show to discuss her background in quality assurance, compliance and auditing within the pharmaceutical industry09:43 – Trends in quality auditing that B...
003 Effective Strategies for Early Stage Drug Development - Judy Magruder (00:28:41)
What We Covered02:10 – Judy Magruder joins the show to discuss her background in early stage drug development and best practices for creating integrated product plans06:21 – Judy provides her insights...
002 Establishing Regulatory Starting Materials & Understanding the ICH - James Mencel (00:35:16)
What We Covered00:54 – James continues his discussion of expedited drug development programs, focusing on the importance of establishing regulatory starting materials07:34 – James provides best practi...
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