164 - Tiny Particles, Big Impact: Breaking down USP 788 & USP 790
In this episode, Subhi Saadeh delves into the specifics of USP chapters 788 and 790, which focus on the testing and acceptance criteria for sub-visible and visible particles in injectable drug product...
27 Marras 202413min
163 - ICH Q12, Established Conditions, Post-Approval Changes, PACMP's, and the Pharma Lifecycle
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 ...
20 Marras 202411min
162 - Philip Crosby’s 5 Bad Beliefs About Quality (And How to Avoid Them)
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, w...
12 Marras 202417min
161 - ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in Medical Devices, Pharma and Combination Products
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, key e...
6 Marras 202424min
160 - Drug Tech Transfer vs. Device Design Transfer EXPLAINED!
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 comprehensive...
30 Loka 202419min
159 - Centralized, Decentralized & Federated Quality Models, McKinsey Study, and QA vs. QC with Ben Locwin
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 engagi...
23 Loka 202422min
158 - 3 Years Straight of Drug/Device Podcasting, Guarding the Process, and the Future of the Show
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 con...
16 Loka 202421min
157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura
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. Ch...
9 Loka 202421min
