258 - Combination Product Quality: Human Factors, CDMO Scorecards, ISO 14971 vs. ICH Q9, with Ben Locwin
Combination product quality with Ben Locwin: why drug and device quality systems differ, how human factors studies are designed, what to do when a CDMO's clean audit doesn't match its performance, and...
12 Okt 34min
257 - 21 CFR Part 4 Explained: CGMP Requirements for Combination Products
21 CFR Part 4 sets the CGMP requirements for combination products. If your product has a drug and a device in it, you're on the hook for both sets of regulations. In this video, I walk through Part 4 ...
5 Okt 12min
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
252 - Acceptance Sampling Fundamentals: AQL, Attributes vs Variables, and Risk (OC Curves)
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 an AQL actually m...
31 Aug 13min
