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 ...
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 ...
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 ...
RAPS

FDA warns five device makers for Quality System, CAPA issues

The US Food and Drug Administration (FDA) has warned five medtech companies for failing to meet current good manufacturing practices (CGMP) requirements under the Quality System (QS) regulations. The ...
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

Cybersecurity and US FDA Requirements Webinar: How Cybersecurity is Introduced into the CGMPs, Design Control (21 CFR 820.30) for Devices, and Post-production by the CAPA ...

DUBLIN--(BUSINESS WIRE)--The "Cybersecurity and US FDA Requirements - Webinar" webinar has been added to ResearchAndMarkets.com's offering. There are regulations such as 21 CFR Part 11 in the U.S. and ...