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 Des 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 Des 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 Des 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
212 - What 6 of the World’s Biggest Companies Taught Him About Combination Products
In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh speaks with Leonel Venegas, a seasoned quality and regulatory professional who has worked with global leaders including Alexion, ...
5 Nov 202525min
211 - Inside FDA’s Office of Combination Products: History, PMOA, and What’s Next for Combination Products with Mark Kramer
In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh welcomes Mark Kramer, the founding director of FDA’s Office of Combination Products (OCP). Mark takes us on a deep dive into the ...
30 Okt 202546min
