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