Hardware Podcasts

092 - Putting it all together: Drug cGMP’s 210/211/ICH and Device QMS 820/ISO13485 with Aaron Snyder

Let's Combinate · 5 Jul 2023 · 41m

What this episode covers

Aaron Snyder, VP of QA at Allotex and AAMI faculty member, explains the structural differences between Device QSR (21 CFR 820/ISO 13485) and Drug cGMPs (21 CFR 210/211), noting that device regulations evolved into a full quality system including design controls, whereas pharma regulations remain focused on manufacturing and testing. He details his career trajectory from auditing at Covidien and Waters to leading QA at Fresenius Kabi and now Allotex, highlighting the specific challenges combination product teams face when bridging these regulatory frameworks. Snyder also discusses his educational initiatives, including teaching AAMI courses and running the 'Quality Systems Explained' YouTube channel, to simplify complex regulatory requirements for engineers and quality professionals.

Most relevant to

established companies

Topics

Mentioned

Companies
Allotex, Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, General Electric, Pfizer, Merck, Mölnlycke Healthcare
Products
Hepincoded catheter
Also
AAMI, Quality Systems Explained, FDA, CDER, CBER, Primal Video

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