MD&M East

Best Practices: Managing a CAPA System

Establishing a corrective and preventive action (CAPA) system is a quality system regulation (QSR) requirement for medical device firms marketing products in the United States. Although FDA has always ...
MD&M East

Converting CAPA to an Advantage

For two years running, corrective and preventive action (CAPA) problems have been the most cited FDA Form-483 deficiency during inspections of medical device manufacturers (see the “Recent FDA ...

CAPA (Corrective and Preventative Action) Programme Course: Discussion of CAPA Examples and Case Studies to Enhance Course Learning (ONLINE EVENT: June 15, 2026)

Market opportunities include enhancing process efficiency and compliance in pharma, biotech, device, and animal health industries through robust CAPA systems. This is crucial as regulatory inspections ...
RAPS

Make CAPA ‘cool’: FDA gives thumbs-up to framework that retools CAPA process for device makers

A new framework that rethinks the corrective and preventive action (CAPA) process by using a risk-based approach has been given the thumbs-up by the US Food and Drug Administration (FDA), with one ...
Business Wire

2023 CAPA (Corrective and Preventative Action) Procedures Training Course: How to Improve your Processes and Implement and Document an Effective CAPA Quality System ...

DUBLIN--(BUSINESS WIRE)--The "CAPA (Corrective and Preventative Action) Training Course" conference has been added to ResearchAndMarkets.com's offering. This course has been specifically designed for ...