Hello Combi-Nation! Our industry fee complicated sometimes. Drugs, devices, clinical trials, submissions, sterilization validation, design control, risk management, market access reimbursement, the list goes on. My name is Subhi Saadeh. I've spent over a decade in medical device, pharma, and combination product development. My goal is mastery, so this podcast is to ask questions I have to people w... more
Publishes | Weekly | Episodes | 214 | Founded | 4 years ago |
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Number of Listeners | Categories | Life SciencesScience |
As AI becomes more integrated into pharmaceutical manufacturing, the question is not just how fast we can adopt it, but how safely. In this episode, Ben Locwin and Subhi Saadeh discuss the intersection of AI, GMP, and Quality 4.0, exploring both the ... more
In this episode, I talk with Monika Andraos of Dunamis Compliance about how organizations can navigate group think and approach data integrity the right way.
We cover risk culture, CSV vs. data integrity, ALCOA++, data governance, and practical tip... more
In this episode, Jesse Gordon-Blake, PhD, delves into the intricacies of medicinal chemistry, particularly focusing on drug discovery for ALS (amyotrophic lateral sclerosis). Jesse explains the process of discovering molecules that modulate biologica... more
In this episode, Subhi Saadeh sits down with Alan Stevens, CAPT, to break down the concept of five nines (99.999% reliability) in medical devices. They cover where the standard came from, why FDA introduced it in their 2020 draft guidance, and what i... more
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As a young biomedical engineer in BioPharmTech, this podcast is a good resource for pertinent topics in the medical device/pharmaceutical world. The only critique I have is the audio quality could be better. The sound cuts in and out sometimes for the guests. I'm guessing the audio is extracted from a zoom or teams interview. The host would serve himself well with a better mic and recording in a better studio-like room setting
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Focused on the intersection of pharmaceuticals and medical devices, the content features in-depth conversations with industry experts about the complexities involved in combination products. Topics range from regulatory affairs and quality management to clinical trial design and risk management, providing valuable insights for professionals in the life sciences sector. The unique conversational style invites both newcomers and seasoned veterans to explore critical issues, innovations, and best practices within the field, encouraging a collaborative approach to problem-solving and knowledge sharing.
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Let's Combinate launched 4 years ago and published 214 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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Recent guests on Let's Combinate include:
1. Monika Andraos
2. Susan Needle
3. Joey Frechin
4. Jeff Gensler
5. Mark Burchnall
6. Archana Sah
7. Mike Denzer
8. Kirk Petyo
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