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
209 - ALCOA++ EXPLAINED | What Everyone Gets Wrong About Data Integrity with Monika Andraos
In this episode, I talk with Monika Andraos of Dunamis Compliance about how organizations can navigate group think and approach data integrity the right way. We cover risk culture, CSV vs. data integr...
8 Loka 202522min
208 - How Drugs Are Designed, Targets, Phenotypes, and Structure Based Design
In this episode, Jesse Gordon-Blake, PhD, delves into the intricacies of medicinal chemistry, particularly focusing on drug discovery for ALS (amyotrophic lateral sclerosis). Jesse explains the proces...
1 Loka 202528min
207 - What 99.999% Reliability Really Means
In this episode, Subhi Saadeh sits down with Alan Stevens, CAPT, to break down the concept of five nines (99.999% reliability) in medical devices. They cover where the standard came from, why FDA intr...
24 Syys 202523min
206 - Will AI Decide Your Next Drug/Device Approval?
Artificial Intelligence is moving fast but how do you regulate it in industries where precision and risk management are everything?In this episode of Let’s Combinate, Subhi Saadeh sits down with Domin...
17 Syys 202531min
205 - Why Less Than 20% of Companies Have Started Quality 4.0
Nearly two-thirds of companies believe Quality 4.0 will transform their operations in the next five years yet fewer than 20% have started, and most haven’t even reached the planning stage. In this con...
11 Syys 202535min
204 - The Dictionary & Thesaurus of Combination Products (Finally Explained) with Susan Neadle
In this episode of Let’s ComBinate: Drugs + Devices, we welcome back Susan Neadle, author of The Combination Products Handbook. Susan explores the persistent and evolving challenge of terminology in c...
3 Syys 202532min
