Blog » Archive by category "capa"

FMEA Methodology As It Relates To The FDA And Medical Devices 

June 6th, 2014 by Zuhdi Hussein

Although it was originally developed for high-risk military assessments,. [...] Read More

Posted in Risk Management System

Improving 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. [...] Read More

Posted in Quality Management System

Quality Management Steps of Risk Assessment

May 22nd, 2014 by Henry Macartney

Quality risk management implementation identifies and manages risks; under. [...] Read More

Posted in Quality Risk Management

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. [...] Read More

Posted in Supply Chain Management

Understanding The CAPA Process During FDA Medical Device Compliance Inspections

April 14th, 2014 by Zuhdi Hussein

In order to go public in the USA with a medical device, developers must pass. [...] Read More

Posted in mock audits

Demystifying FDA Corrective and Preventive Actions

February 6th, 2014 by James Francum

Regulations outlined in FDA CFR 21 state that manufacturers must implement and. [...] Read More

Posted in GxP CC

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