Let's Combinate - Drugs + Devices
Subhi SaadehHello 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 | 246 | Founded | 5 years ago |
|---|---|---|---|---|---|
| Number of Listeners | Categories | Life SciencesScience | |||
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Latest Episodes
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
In this episode, Subhi breaks down Q11 by focusing on three key sections: how the drug substance process is developed, where that process begins, and how it is controlled.
He places Q11 in context with Q7 for API GMP, Q8 for pharmaceutical developme... more
Six Major Auditing Strategies: Tracing, Process, Department, Element, Process-Based Management, and Discovery
Course Link: cqeacademy.teachable.com/p/the-cqa-master-class-course
In this episode, Subhi explains why selecting the right auditi... more
his episode looks at where Q10 fits in the broader quality landscape, including its roots in ISO 9001, ISO 9004, and ISO 13485, while making the key distinction that Q10 is not a certifiable ISO-style standard. Instead, Q10 is designed to augment reg... more
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- Great content and knowledgeable guests
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
Apple Podcasts4lblake09
United States2 years ago
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Apple Podcasts | #134 |  Canada/Science/Life Sciences |
Apple Podcasts | #49 |  India/Science/Life Sciences |
Apple Podcasts | #90 |  Finland/Science/Life Sciences |
Apple Podcasts | #109 |  Denmark/Science/Life Sciences |
Apple Podcasts | #126 |  South Korea/Science/Life Sciences |
Apple Podcasts | #143 |  Belgium/Science/Life Sciences |
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Frequently Asked Questions About Let's Combinate
What is Let's Combinate about and what kind of topics does it cover?
A commercially focused deep-dive into drug-device development, regulatory strategy, and quality management for life sciences. Episodes frequently cover ICH guidelines, regulatory pathways across regions, post-market lifecycle considerations, and practical challenges in combining drugs with devices. Conversations with industry professionals explore CAPA, stability, validation, manufacturing, and global standards, often tying theory to real-world applications for teams working at the intersection of pharma and medtech. Notably, the show emphasizes bridging pharmaceutical and device expectations, helping listeners streamline development, compliance, and market access while highlighting practical pitfalls and process improvements.
Where can I find podcast stats for Let's Combinate?
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How many listeners does Let's Combinate get?
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What are the audience demographics for Let's Combinate?
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How many subscribers and views does Let's Combinate have?
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Which podcasts are similar to Let's Combinate?
These podcasts share a similar audience with Let's Combinate:
1. The Daily
2. Hidden Brain
3. Planet Money
4. This American Life
5. Up First from NPR
How many episodes of Let's Combinate are there?
Let's Combinate launched 5 years ago and published 246 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.
How do I contact Let's Combinate?
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What guests have appeared on Let's Combinate?
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
To view more recent guests and their details, simply upgrade your Rephonic account. You'll also get access to a typical guest profile to help you decide if the show is worth pitching.