
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 | 249 | Founded | 5 years ago |
|---|---|---|---|---|---|
| Number of Listeners | Categories | ScienceLife Sciences | |||

One of the hardest parts of auditing is not knowing what to look for.It is deciding where to start. Do you trace a deviation? Walk the process? Focus on one department? Audit CAPA across the organization? Or pull on a thread that does not quite make ... more
In this final episode of the ICH Quality series, we walk through the most important concepts in ICH Q14 and how they fit into the broader ICH quality framework.
Rather than reviewing the guideline section by section, this episode focuses on the idea... more
ICH Q13 explains how pharmaceutical companies can apply batch definition, traceability, control strategy, validation, release, and lifecycle management to continuous manufacturing of drug substances and drug products.Learn more:www.letscombin... more
In this episode, Subhi breaks down ICH Q12, the guideline focused on post-approval change management and pharmaceutical product lifecycle management.
The core question behind ICH Q12 is simple: once a product is approved, what is actually binding, w... 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
Key themes from listener reviews, highlighting what works and what could be improved about the show.
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The show centers on the regulatory, quality, and development challenges in the pharma, medical device, and combination products space, guided by practical host-led explanations and real-world anecdotes. Episodes frequently cover ICH guidelines, GMP, CAPA, design space, and market/regulatory strategy, often featuring experts who discuss material selection, regulatory pathways in different regions, and audit or testing frameworks. A notable strength is the host's ability to translate complex standards into actionable guidance for practitioners, with a bias toward risk management, lifecycle thinking, and cross-functional collaboration that helps listeners anticipate issues in development, submission, and post-market activities.
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Let's Combinate launched 5 years ago and published 249 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. Lucas Pianegonda
2. Joe Luminiello
3. Jennifer Rider
4. Georg Digel
5. Elaine Tan
6. Stephen O'Rourke
7. Andy Robertson
8. Usman Ahmed
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