220 - Managing Oneself, Reflections and a New Series on ICH
🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️ Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letsc...
31 Dec 20258min
219 - FDA PreCheck and the Future of Inspections: PAI to Pre-Readiness
In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh is joined by Ben Locwin to break down what’s changing in FDA pre-approval and pre-license inspections—and why the “inspection sid...
24 Dec 202525min
218 - ICH Q13: Continuous Manufacturing EXPLAINED (Batch vs. Continuous)
In this short episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh breaks down ICH Q13 and what “continuous manufacturing” actually means. He compares batch vs. continuous, explains how a batch s...
17 Dec 20259min
217 - 5 Fixable Problems Holding Back Drug–Device Programs
In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh addresses five significant quality issues in the combination product space. This episode provides practical insights and strategi...
10 Dec 202517min
216 - How UAE and Singapore Are Redefining Regulatory Innovation with Stephen O'Rourke
In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh speaks with Steven O'Rourke, regulatory strategist and founder of Clarifi, a consultancy helping MedTech, biotech, and novel food...
3 Dec 202521min
215 - Why Aren’t Technical People Leading Drug-Device Audits?
In this episode of Let’s Combinate, Subhi Saadeh breaks down why more engineers in pharma, medical devices, and combination products should seriously consider becoming auditors. Sparked by a question ...
26 Nov 202513min
214 - The Best 5 Certifications for ANY Quality Career Path (CQE, Green Belt, CQA & More)
In this episode of Let's Combinate: Drugs + Devices host Subhi Saadeh welcomes back Andy Robertson, founder of CQE Academy. Andy shares his transformative journey involving CQE certification and how i...
19 Nov 202519min
213 - From Generic Underdog to Billion‑Dollar Exit: How Usman Ahmed Built & Sold a Sterile Injectable Site
What happens when you go all in on a generic injectable that no one else wants, and it turns into a one hundred million dollar product in the first year?In this episode of Let’s Combinate: Drugs + Dev...
12 Nov 202543min
