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 | 191 | Founded | 4 years ago |
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Number of Listeners | Categories | ScienceLife Sciences |
In this episode of Let’s Combinate, Subhi Saadeh—an ISO 13485 certified lead auditor, CQA, and CQE—dives into the evolving role of auditing in the medical device and pharmaceutical industries. He reflects on his journey to becoming a Certified Qualit... more
What’s the difference between Quality by Design (QbD) and Design Controls—and why should you care if you're developing drug-device combination products?
In this episode of Let’s Combinate, Subhi Saadeh breaks down the key distinctions between QbD, u... more
In this episode of Let's Accommodate Drugs and Devices, host Subhi Saadeh shares four pieces of timeless career advice inspired by Morgan Housel's book, 'Same as Ever'. This episode is particularly aimed at bioengineering students and early-career pr... more
In this episode of Let's Combinate, host Subhi Saadeh is joined by Aaron Snyder, the creator of Quality Systems Explained and a seasoned consultant in regulated quality systems. The discussion revolves around the critical role of documentation in qua... 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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This podcast explores the intricate interplay between pharmaceuticals and medical devices, focusing on a broad range of topics relevant to industry professionals. Episodes cover critical themes such as quality management systems, product development, regulatory compliance, and innovations in drug delivery methods. Notable discussions include mentorship in the industry, in-depth examinations of regulatory practices, and insights from experts on leadership and quality ownership. Uniquely, the host draws from over a decade of experience in the field, encouraging a journey towards mastery for listeners at all levels of expertise, making this a valuable resource for anyone involved in the life sciences sector.
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Let's Combinate launched 4 years ago and published 191 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. Skip Creveling
2. Eric Sugalski
3. Gwen Acton
4. Joanna Gallant
5. Catherine Ebon
6. Shelly Amster
7. Doug Mead
8. Dr. Timothy Aungst
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