250 - PIC/S PI 006-4 (2026): What Changed in Qualification & Validation?
PIC/S has issued its first major update to its qualification and validation recommendations in nearly 20 years. PI 006-4 replaces PI 006-3 from 2007 and brings the document much closer to how qualific...
12 Elo 11min
249 - The Best Audit Advice Nobody Told Me
Audits are not supposed to be gotchas, and they are not meant to evaluate one person’s work in isolation. A good audit looks at whether a system is suitable, effective, and adequate and where it may n...
5 Elo 14min
248 - What Is a Quality Unit? QA vs. QC Explained
What is a Quality Unit and how do Quality Assurance and Quality Control fit within it?In this episode, I explain the practical differences between the Quality Unit, QA, and QC across pharmaceutical, m...
29 Heinä 8min
247 - Why Everyone in Pharma and MedTech Should Work in Quality
Quality is often treated like a necessary function rather than an exciting career path. But working in quality can give professionals in pharma, biotech, and MedTech a much broader understanding of ho...
22 Heinä 8min
246 - The 3 Ways to Structure a Quality Management System (Centralized vs. Federated vs. Decentralized)
Most discussions about One QMS focus on harmonization.But before deciding whether a single global Quality Management System is the right approach, it's worth understanding the three primary ways organ...
15 Heinä 8min
245 - Reducing a 14-Step Emergency Injection to a Two-Step Auto-Injector
In this episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh talks with Julia Anthony, founder and chief strategy officer of Solution Medical, about adrenal crisis, emergency hydrocortisone, and ...
8 Heinä 45min
244 - 5 Critical Quality Differences Between Drugs and Devices
Download the free Drug vs. Device Quality comparison guide here: https://letscombinate.kit.com/216fbfc6c2In this Let’s Combinate episode, Subhi explains why drug and device quality are not the same an...
1 Heinä 8min
