CMC Live - Chemistry, Manufacturing & Controls
Meranda Parascandola, Ed NarkeFDA 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 Devel... more
| Publishes | Weekly | Episodes | 27 | Founded | 5 years ago |
|---|---|---|---|---|---|
| Categories | How ToEducationChemistryScience | ||||
Listen to this Podcast
Latest Episodes
What We Covered
• 00:55 – 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 Parenteral Drug Association (PDA)
• 07:51... more
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) Explained!
• 07:53 – The panel expounds on the timing necessary for QMS and what role the quality manua... more
What We Covered
• 00:52 – Ed, Meranda and Brian welcome back Jim Mencel who shares his extensive experience with process validation
• 07:46 – The importance of Proven Acceptable Range (PAR) and Critical Process Parameter Program (CPP)
• 11:14 – Th... more
What We Covered
• 00:51 – 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 the process of selecting a filter and why n... more
Key Facts
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Reviews
- Great Perspectives on CMC!
Great to hear some diverse topics and perspectives about CMC on a podcast! This platform is much easier to get current thinking on regulatory guidelines while driving.
Apple Podcasts5Cryophorous
United States4 years ago
Chart Rankings
How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.
Apple Podcasts | #42 | United States/Science/Chemistry |
Apple Podcasts | #24 |  Germany/Science/Chemistry |
Apple Podcasts | #57 |  France/Science/Chemistry |
Apple Podcasts | #13 |  Finland/Science/Chemistry |
Apple Podcasts | #18 |  Sweden/Science/Chemistry |
Apple Podcasts | #22 |  Taiwan/Science/Chemistry |
Audience Metrics
Listeners, social reach, demographics and more for this podcast.
| Gender Skew | Location | Interests | |||
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| Professions | Age Range | Household Income | |||
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CMC Live launched 5 years ago and published 27 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.
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