In this episode of Let's Combinate, host Subhi Saadeh delves into the significance of ICH Q12 for the pharmaceutical industry, especially concerning established conditions and drug-device combination products. Subhi explains

In this episode, Subhi delves into 'Quality is Free' by Philip Crosby, a seminal book in quality management. Highlighting its personal significance, the host discusses the core concept that quality,

In this episode of Let's Combinate, host Subhi Saadeh explores the essential frameworks of risk management in medical devices and pharmaceuticals: ISO 14971 and ICH Q9. He discusses the origins,

In this episode of *Let's Combinate*, Subhi delves into the critical distinctions between drug tech transfer and device design transfer, especially pertinent to combination products. Sue comprehensively outlines the regulatory

In this informative episode of Let's Combinate, host Subhi Saadeh and frequent guest Ben delve into the key aspects of quality management across various organizational structures. Through their engaging discussion,

In this episode, host Subhi reflects on three years of podcasting, drawing analogies to strength training and discussing the incremental progress achieved. The episode highlights the importance of consistency in

In this episode of the Combinate Podcast, host Subhi Saadeh welcomes back Chuck Ventura, founder of Ventura Solutions, to discuss the often overlooked topic of design inputs in product development.

On this episode, I was joined by Laxman Halleppanavar, Head of Portfolio Strategy and Management at Credence MedSystems, Inc. On this episode, Laxman, highlights the differences in regulatory oversight and

On this episode, I was joined by Laurie Auerbach, President and Principal Consultant, Compliance Prodigies, LLC. In this episode, Laurie dives into the complexities of FDA compliance programs, specifically focusing

On this episode, I was joined by Devon Campbell, Founder and Managing Director of Prodct. Devon covers the differences between IVDs, companion diagnostics, and precision medicine, the risk management aspects

On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran explores the

This episode is a cross-post of an interview I did with Etienne Nichols over at the Global Medical Device Podcast at GreenLight Guru (Episode #380) . In this episode, Etienne