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Featured Articles

June 2011


John Nugent

How to Build a Business Case for a Quality Management System

by Jon Nugent
Managing Director of Client Services, Business Intelligence Solutions

It is impossible for FDA regulated manufacturers to conduct business without paying close attention to regulatory compliance.

FDA regulations can introduce increasing complexity into internal business processes, delaying the pace of innovation and new product introduction. Also, complying with regulations is expensive, with the cost of compliance now estimated at two percent of revenues. This expense, however, pales in comparison to the potential costs and risks associated with non-compliance.

Investing in a scalable, enterprise compliance solution can have significant top-line and bottom-line benefits that extend well beyond simply achieving compliance.

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John E. Lincoln

Product Risk Management Under ISO 14971:2007 and ICH Q9

by John E. Lincoln
J.E. Lincoln and Associates LLC

Risk management has many connotations depending upon the audience. Its definition depends upon whether the context is company disaster recovery, company/product liability, protection of intellectual property, protection of the data processing system and data, and similar. This article covers medical device and pharmaceutical hazard analysis and risk management.

All medical interventions involve some level of risk, which is acknowledged on the FDA's website and within ISO 14971:2007 standards. The goal of the responsible manufacturer is to reduce product risk and to identify/know the levels of remaining risks, which are tied—ultimately—to a user's (clinician and patient) safety.

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Quality Event Management Audit Workshops
July - October 2011, Various Locations

Quality Event Management CAPA Workshops
July - October 2011, Various Locations

AdvaMed Annual Congress
September 26-28, 2011, Washington DC

RAPS Annual Conference and Exhibition
October 23-26, Indianapolis, IN

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Do you know how to navigate the FDA's website when searching for FDA warning letter information? During the (ACRP) conference it became apparent that many people, including FDA employees, have a difficult time searching for Warning Letters on FDA's website. The Warning Letter section is an absolute mess. So I thought I would provide a few simple search tips to help find Warning Letters for GCPs. Unfortunately cGMP Warning Letters are more difficult but the tips still help.
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