Although it was originally developed for high-risk military [...] Read More
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May 29th, 2014 by James FrancumCorrective 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 MacartneyQuality 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 MacartneyAs 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
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February 6th, 2014 by James FrancumRegulations 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