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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2023-07-05
- Length: 41m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-05-092-putting-it-all-together-drug-cgmps-210-211-ich-and-device-qms-820-iso13485-w
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/092---Putting-it-all-together-Drug-cGMPs-210211ICH-and-Device-QMS-820ISO13485-with-Aaron-Snyder-e26i534

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-05-092-putting-it-all-together-drug-cgmps-210-211-ich-and-device-qms-820-iso13485-w#t=0) Introduction: Aaron Snyder and Allotex
- [2:13](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-05-092-putting-it-all-together-drug-cgmps-210-211-ich-and-device-qms-820-iso13485-w#t=133) Device QSR vs. Drug cGMPs: Evolution of Regulations
- [7:10](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-05-092-putting-it-all-together-drug-cgmps-210-211-ich-and-device-qms-820-iso13485-w#t=430) Combination Products and FDA CDER/CBER Training
- [13:23](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-05-092-putting-it-all-together-drug-cgmps-210-211-ich-and-device-qms-820-iso13485-w#t=803) Cross-Industry Struggles: Pharma to Device and Vice Versa
- [20:46](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-05-092-putting-it-all-together-drug-cgmps-210-211-ich-and-device-qms-820-iso13485-w#t=1246) Aaron Snyder's Career: From Covidien to Allotex
- [28:23](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-05-092-putting-it-all-together-drug-cgmps-210-211-ich-and-device-qms-820-iso13485-w#t=1703) Teaching at AAMI and the 'Quality Systems Explained' YouTube Channel
- [37:35](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-05-092-putting-it-all-together-drug-cgmps-210-211-ich-and-device-qms-820-iso13485-w#t=2255) Recommended Books: The War of Art and Rich Dad Poor Dad

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)

## Most relevant to

established companies

## Mentioned

- Allotex (company)
- Fresenius Kabi (company)
- Molnlycke (company)
- Waters Corporation (company)
- Covidien (company)
- Cardinal Health (company)
- General Electric (company)
- AAMI (other)
- Quality Systems Explained (other)
- Pfizer (company)
- Merck (company)
- FDA (other)
- CDER (other)
- CBER (other)
- Hepincoded catheter (product)
- Mölnlycke Healthcare (company)
- Primal Video (other)

## Related episodes from other shows

- [#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment) (Global Medical Device Podcast)
- [#380: Navigating the Complex World of Combination Products with Subhi Saadeh](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh) (Global Medical Device Podcast)
- [QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-03-16-qmsr-the-future-of-fdas-quality-management-system-regulation-for-medical-devices) (Global Medical Device Podcast)
- [#438: QMSR Mythbusters Episode](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-12-22-438-qmsr-mythbusters-episode) (Global Medical Device Podcast)
- [#329 The Right Way to Start a QMS: When, How, & What](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-07-27-329-the-right-way-to-start-a-qms-when-how-what) (Global Medical Device Podcast)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-05-092-putting-it-all-together-drug-cgmps-210-211-ich-and-device-qms-820-iso13485-w. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.