Hardware Podcasts

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

Let's Combinate · 5 Mar 2025 · 31m

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

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

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