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 Joulu 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 Marras 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 Marras 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 Marras 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 Marras 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 Loka 202546min
210 - The 8 Roles You MUST Understand in Pharma & MedTech
I get a lot of questions from students and early-career professionals about what different industry roles actually mean: what does a Quality Engineer do? What’s Regulatory Affairs? How does R&D fit in...
22 Loka 202519min
210 - How AI Is Rewriting GMP: Smarter CAPA, PAT, DOE, and Continuous Yield
As AI becomes more integrated into pharmaceutical manufacturing, the question is not just how fast we can adopt it, but how safely. In this episode, Ben Locwin and Subhi Saadeh discuss the intersectio...
15 Loka 202522min
