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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

Preparing A Superior Audit Checklist With FDA 21 CFR 210

May 27th, 2014 by Zuhdi Hussein

It's hard to navigate in the dark, and although FDA regulations can seem. [...] Read More

Posted in life science compliance consultants

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

Improve Record Keeping With 21 CFR Part 11

May 20th, 2014 by James Francum

Electronic record keeping is an essential yet complex part of running a life. [...] Read More

Posted in IT software validation

Are You Up To Speed On The FDA's New Regulation On Supply Chain Integrity

May 16th, 2014 by Henry Macartney

The Division of the Supply Chain Integrity of the FDA has two main goals, which. [...] Read More

Posted in the Drug Supply Chain Security Act (DSCSA) Title I

Implementing Comprehensive Quality Systems For FDA Medical Device QSR And Other Regulations

May 12th, 2014 by Zuhdi Hussein

The FDA's Quality System Regulation shouldn't act as a hindrance to medical. [...] Read More

Posted in Quality System Regulation 21 CFR 820

GxP-CC Earns ISO 9001:2008 Certification

May 8th, 2014 by James Francum

GxP-CC has achieved ISO 9001:2008 certification. Developed by the International. [...] Read More

Posted in training

Staying Up-To-Date With FDA Pharmaceutical cGMPs

May 5th, 2014 by James Francum

Your firm's pharmaceutical products aren't the only things subject to U.S. and. [...] Read More

Posted in GxP CC

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