In this episode of Let's Combinate, host Subhi Saadeh highlights five critical aspects of the FDA's new Quality Management System Regulation (QMSR) that you may have missed. Subhi explains the
In this episode of Let’s Combinate, host Subhi Saadeh breaks down the critical role of quality agreements in the pharmaceutical and medical device industries.A quality agreement is a written document
From Episode 195 with Archana Sah In this clip of the larger interview with Archana Sah, she covers the critical phases and elements of clinical trials—from phase one focusing on
In this episode, I go over 8 lessons to maximize your first 90 days in Life Sciences. These include understanding the impact of their roles, adopting a professional mindset, passing
In this episode of Let's Combinate, Archana shares her insights on the critical factors involved in designing clinical trials, from phase one safety profiling to pivotal phase three trials. She
In this episode I sit down with Mike Denzer, a mechanical engineer, inventor, and trusted leader in the combination product space. We talk about the power of networking not just
In this episode of Let’s Combinate, host Subhi Saadeh is joined by Kirk Petyo, Partner at Talent Factory Medical and Talent Factory Recruiting. If you’re a bioengineering student, recent grad,
If you’ve ever wondered what a combination product is—or how to explain it—this video breaks it down clearly and simply. This is a non-technical, high-level explanation of what a combination
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
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
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
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
