# 178 - CAPA Face-Off: Pharma vs. MedTech – Key Differences You Need to Know

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-03-05
- Length: 31m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-03-05-178-capa-face-off-pharma-vs-medtech-key-differences-you-need-to-know
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/178---CAPA-Face-Off-Pharma-vs--MedTech--Key-Differences-You-Need-to-Know-e2vl502

## Summary

Aaron Snyder, founder of Quality Systems Explained and former VP of QA at Allotex, explains the regulatory and operational differences in CAPA (Corrective and Preventive Action) between pharmaceutical and MedTech industries. He highlights that while Pharma regulations (21 CFR 210/211) focus on 'deviations' and MedTech (21 CFR 820) mandates 'corrective and preventive action,' effective systems in both sectors perform similar root cause investigations. Snyder emphasizes that CAPA systems fail without strong management support, leading to 'birthday' CAPAs that remain open for years, and advocates for structured root cause tools like Ishikawa diagrams over manipulated 5 Whys.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2025-03-05-178-capa-face-off-pharma-vs-medtech-key-differences-you-need-to-know#t=0) Introduction: Aaron Snyder and Quality Systems Explained
- [0:44](https://hardwarepodcasts.com/podcast/lets-combinate/2025-03-05-178-capa-face-off-pharma-vs-medtech-key-differences-you-need-to-know#t=44) Regulatory Origins: 21 CFR 210/211 vs 21 CFR 820.100
- [3:12](https://hardwarepodcasts.com/podcast/lets-combinate/2025-03-05-178-capa-face-off-pharma-vs-medtech-key-differences-you-need-to-know#t=192) Terminology Gaps: Deviations, Non-conformances, and Events
- [8:13](https://hardwarepodcasts.com/podcast/lets-combinate/2025-03-05-178-capa-face-off-pharma-vs-medtech-key-differences-you-need-to-know#t=493) System Effectiveness: Risk-based CAPA vs. Batch-level Investigations
- [13:56](https://hardwarepodcasts.com/podcast/lets-combinate/2025-03-05-178-capa-face-off-pharma-vs-medtech-key-differences-you-need-to-know#t=836) Quality Standards: ISO 9001, ISO 13485, and ICH Q10
- [19:13](https://hardwarepodcasts.com/podcast/lets-combinate/2025-03-05-178-capa-face-off-pharma-vs-medtech-key-differences-you-need-to-know#t=1153) Verification of Effectiveness and Change Control Gaps
- [22:21](https://hardwarepodcasts.com/podcast/lets-combinate/2025-03-05-178-capa-face-off-pharma-vs-medtech-key-differences-you-need-to-know#t=1341) Management Support and the Problem of 'Birthday' CAPAs
- [26:39](https://hardwarepodcasts.com/podcast/lets-combinate/2025-03-05-178-capa-face-off-pharma-vs-medtech-key-differences-you-need-to-know#t=1599) Root Cause Analysis: Ishikawa Diagrams vs. 5 Whys

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)
- [Debugging & failure analysis](https://hardwarepodcasts.com/topic/debugging-and-failure-analysis)

## Most relevant to

early-stage companies

## Mentioned

- Quality Systems Explained (other)
- Allotex (company)
- Fresenius Kabi (company)
- Molnlycke (company)
- Waters Corporation (company)
- Covidien (company)
- Cardinal Health (company)
- General Electric (company)
- AAMI (other)
- Combination Products Coalition (other)
- ASTM Committee E55 (other)
- 21 CFR 210 (other)
- 21 CFR 211 (other)
- 21 CFR 820 (other)
- ICH Q10 (other)
- ISO 9001 (other)
- ISO 13485 (other)
- Ishikawa (other)
- 5 Whys (other)

## Related episodes from other shows

- [Does Your CAPA Process Need a CAPA?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-08-24-does-your-capa-process-need-a-capa) (Global Medical Device Podcast)
- [What are the Top Compliance Issues Plaguing Medical Device Manufacturers?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-11-10-what-are-the-top-compliance-issues-plaguing-medical-device-manufacturers) (Global Medical Device Podcast)
- [Most Common Problems Found During FDA Inspections in 2022](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-03-23-most-common-problems-found-during-fda-inspections-in-2022) (Global Medical Device Podcast)
- [#388: Elements of an Effective CAPA Program](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-10-24-388-elements-of-an-effective-capa-program) (Global Medical Device Podcast)
- [Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-06-14-top-3-most-cited-issues-in-medical-device-inspections-from-fda-fy2020) (Global Medical Device Podcast)

## Citing this page

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