256 - The New FDA Inspection Playbook: Where to Start with QMSR
QMSR became effective on February 2, 2026. Alongside that change, FDA retired the Quality System Inspection Technique (QSIT) and began using the inspection process described in Compliance Program 7382...
28 Sep 9min
255 - Audit Interview Techniques: How Good Auditors Get Better Evidence
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 this ...
21 Sep 11min
254 - Saying No Is the Easy Part of Quality
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 Quality should abs...
13 Sep 12min
253 - FDA Is Making Big Changes to Its Inspection Approach
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 approximately 800+ insp...
7 Sep 45min
251 - The Future of Drug Delivery: Orals, Injectables, Sustainability & Device Strategy
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 del...
24 Aug 49min
I'm Changing The Podcast
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, listens, shares, or h...
18 Aug 2min
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 Aug 11min
