Category: CAPA

CAPA Initiation – Containment & Correction Actions

By Shant Youkhana, Director of Quality and Strategic Solutions The Corrective and Preventative Action (CAPA) system is a regulatory requirement to which all Medical Device, Pharmaceutical, and Combination Product manufacturers must comply. Although there are minor differences between the CAPA system requirements in the Medical Device and Pharmaceutical industries, the overall purpose remains the same:…