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 Okt 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 Okt 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 Sep 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 Sep 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 Sep 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 Sep 202532min
203 - Drug Delivery, Platforms, IP Battles, Supply Chain Risks with Jim Collins
In this episode of Let’s Combinate, Subhi Saadeh sits down with Jim Collins, a leader in drug delivery with over 30 years of experience at Eli Lilly, Sanofi, and now as an advisor and board member. Ji...
27 Aug 202545min
202 - Becoming an Expert in the Work Nobody Wants to Do/Design, Risk, and the Messy Middle of Combination Products w/Joey Frechin
In this episode of Let's Combinate, host Subhi Saadeh is joined by long-time friend and Senior Technical Program Manager Joey Frechin, who brings a wealth of experience in med tech consulting. They di...
20 Aug 202532min
