A huge part of the job is knowing how to interview people, understand how work is actually performed, and corroborate what you hear against records, observations, and other objective evidence.In
Quality has a reputation for saying no. Sometimes that’s exactly the right call. Other times, “no” is just the easiest answer. In this episode, Subhi breaks down four situations where
FDA is changing how it organizes and deploys its investigators but it isn’t simply returning to the old generalist model. Eric Pittman spent more than 20 years at FDA, conducted
Acceptance sampling is one of the most commonly used and commonly misunderstood tools in quality. In this video, I break down the fundamentals of acceptance sampling: what it is, what
In this episode, Subhi Saadeh sits down with Steven Kaufman, Founder of Combination Product Solutions, Inc. and fractional Chief Commercial Officer at Portal Instruments, to discuss where the drug delivery
After 250 straight weeks of publishing Let’s Combinate every Wednesday, I’m making a change. Starting now, new episodes will go live Mondays at 5:00 AM CT. To everyone who watches,
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
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,
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
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
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 organizations
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 what
