Although it was originally developed for high-risk military [...] Read More
FMEA Methodology As It Relates To The FDA And Medical Devices
June 6th, 2014 by Zuhdi HusseinImproving CAPA in the Regulated Industries
May 29th, 2014 by James Francum
Corrective and preventive actions, or CAPAs, play a vital role in how GxP firms maintain compliance with FDA standards. A corrective action (CA) is an action [...] Read More
Quality Management Steps of Risk Assessment
May 22nd, 2014 by Henry Macartney
Quality risk management implementation identifies and manages risks; under normal circumstances the [...] Read More
Can Medical Device Compliance Consulting Benefit You?
April 29th, 2014 by Henry Macartney
As all medical device manufacturers know, life sciences firms are bound by GxP rules and recommendations. Firms [...] Read More
Understanding The CAPA Process During FDA Medical Device Compliance Inspections
April 14th, 2014 by Zuhdi Hussein
[...] Read MoreDemystifying FDA Corrective and Preventive Actions
February 6th, 2014 by James Francum
Regulations outlined in FDA CFR 21 state that manufacturers must implement and maintain processes for corrective and preventive actions. Also known as CAPA systems, the implementations that deal with [...] Read More