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Recent Episodes

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203 - Drug Delivery, Platforms, IP Battles, Supply Chain Risks with Jim Collins
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201 - Inside a $300M FDA Remediation, Lessons from Zimmer to EpiPen Warning Letters, 99.999% Reliability and Quality 4.0
200 - 4 Years of Conversations, and I’m Still Figuring It Out
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198 - QMSR Explained, ISO 13485 Compared, and 5 Key Things You Might’ve Missed
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Welcome to Let’s Combinate! Where we’re mastering medical device and pharma quality - little q!

This channel is dedicated to navigating the world of medical devices and pharmaceuticals, providing insights into the critical standards and regulations that shape the industry. Whether it’s ISO 13485, 21 CFR Part 4/820, PIC/S GMP, ICH Q9/Q10, or EU MDR/IVDR, we focus on making these complex topics accessible and actionable.

We also dive into the unique challenges and opportunities of combination products, exploring the integration of devices, drugs, and biologics.

Let’s ComBinate is hosted by Subhi Saadeh, a Quality Professional with over a decade of experience working on hardware devices, disposable devices, and combination products for vaccines, generics, and biologics. He has also contributed to advancing industry practices with organizations like CPC, ASTM, and AAMI, bringing a well-rounded perspective.

Subscribe now, hit the bell icon, and join us —Let’s ComBinate! 🌍💊🔬

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