Podcast

May 28, 2025

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

May 21, 2025

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

May 14, 2025

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

May 7, 2025

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 breaks

April 30, 2025

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

April 23, 2025

185 – ISO 10013, Document Control in Pharma & Devices: SOPs, Work Instructions, and RACI Done Right with Aaron Snyder

Documentation Hierarchy and Best Practices in Quality Systems with Aaron SnyderIn this episode of Let’s Combinate, host Subhi Saadeh is joined by Aaron Snyder, the creator of Quality Systems Explained

April 16, 2025

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

April 9, 2025

183 – GxP Explained: A Complete Guide to Good Manufacturing, Clinical, Laboratory, and Distribution Practices for Regulated Products

Understanding GXPs: Essential Good Practices for Bioengineering ProfessionalsIn this episode of Let's Combinate, host Subhi Saadeh, a seasoned bioengineer with ten years of experience in the pharma and medical device

April 2, 2025

182 – 7 Powerful Ways to Find Amazing Mentors in Medical Devices and Pharma

In this episode of Let's Combinate, Subhi Saadeh shares personal insights and seven crucial lessons on finding the right mentors in the pharmaceutical and medical devices sectors. Subhi emphasizes the

March 26, 2025

181 – Can Ampoule Drug Delivery Systems REVOLUTIONIZE the Industry?

Discover how ampoule(ampule) drug delivery systems could revolutionize the pharmaceutical industry in this eye-opening video. Learn about the potential impact of this innovative technology on drug administration and patient care.In

March 19, 2025

180 – MIT Leadership Expert Reveals Management Secrets for Scientists!

???? Stay ahead in combination products, pharma, and medical devices ???? https://www.letscombinate.com????️ Listen to more expert discussions on regulations, drug delivery, and quality ???? https://www.letscombinate.com/Get expert insights on FDA regulations,

March 12, 2025

179 – Quality is NOT Everyone’s Job—Why That’s a GOOD Thing

In this episode of Let’s Combinate, host Subhi Saadeh, a seasoned quality professional, delves into the concept of ‘everyone owns quality’ and explains why this notion is flawed. Subhi recalls

Join Our newsletter

Sign up now to stay ahead with our combo product tips and never miss a weekly episode!

By signing up, you agree to receive email from this website.