191 - If It’s Not ALCOA+, It Didn’t Happen: The Real Meaning of Data Integrity
You’ve heard it before: If it’s not documented, it didn’t happen. But in life sciences, documentation isn’t just a formality—it’s the foundation of trust, compliance, and product quality. In this epis...
4 Kesä 202513min
190 - Harmony, Not Sameness: What Drug-Device Teams Keep Getting Wrong
Episode is based on a talk Subhi Saadeh gave at CPHI. In this episode, Subhi Saadeh breaks down the three levels where true harmonization must happen for drug-device products to succeed:-Global regula...
28 Touko 202515min
189 - FDA, ISO, ICH, USP, PDA - What Are These Groups and Why Do They Matter?
Ever wondered who’s really behind the regulations you follow in pharma and medical devices? In this episode of Let’s ComBinate, Subhi Saadeh breaks down the five categories of organizations that influ...
21 Touko 202517min
188 – Certified Quality Auditor(CQA) and Audits in the Future
In this episode of Let’s Combinate, Subhi Saadeh—an ISO 13485 certified lead auditor, CQA, and CQE—dives into the evolving role of auditing in the medical device and pharmaceutical industries. He refl...
14 Touko 202515min
187 - Why Drug and Device Development Use Different Playbooks (QbD vs. Design Controls Explained)
What’s the difference between Quality by Design (QbD) and Design Controls—and why should you care if you're developing drug-device combination products?In this episode of Let’s Combinate, Subhi Saadeh...
7 Touko 202516min
186 - 4 Ways to Future-Proof Your Career in Pharma, Medical Devices and BioTech
In this episode of Let's Accommodate Drugs and Devices, host Subhi Saadeh shares four pieces of timeless career advice inspired by Morgan Housel's book, 'Same as Ever'. This episode is particularly ai...
30 Huhti 202512min
185 - ISO 10013, Document Control in Pharma & Devices: SOPs, Work Instructions, and RACI Done Right with Aaron Snyder
In this episode of Let's Combinate, host Subhi Saadeh is joined by Aaron Snyder, the creator of Quality Systems Explained and a seasoned consultant in regulated quality systems. The discussion revolve...
23 Huhti 202525min
184 - Program Management in Pharma & Devices: Phase Gates, Risk Planning, and Project FMEAs Explained
In this episode of Let's Combinate, host Subhi Saadeh welcomes back Skip Creveling, a global expert in program management and Six Sigma methodologies.Skip shares his extensive experience helping Fortu...
16 Huhti 202530min
