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Featured Articles

                              July - September 2011

Jon 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. And complying with regulations is expensive, with the cost of compliance now estimated at two percent of revenues. The expense, however, pales in comparison to the potential costs and risks associated with non-compliance.

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David Dills

Writing and Enforcing Your SOPs for GxP Compliance Success

by David Dills
Quality & Compliance Advisor

This paper addresses the fundamentals of writing and enforcing your SOPs not only for compliance and in accordance with internal company policies and requirements but certainly for ensuring compliance with FDA requirements as well.

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John A. Challenger

Certification and Advanced Degrees: Are They Worth It?

by John A. Challenger
CEO, Challenger, Gray & Christmas, Inc.

The value of certification and/or advanced degrees, such as an MBA, often comes into question in the wake of economic downturns. There are two camps on the issue. On the one side you have those who spent time and money earning these achievements and now may be questioning the value of these achievements in light of job loss or, at least, job insecurity. The other camp consists of those who don't have advanced education and wonder if obtaining it would help their job search efforts or career aspirations.

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Cathy Crawford

Implementation of Food Safety Modernization Act

by Cathy Crawford
HACCP and Food Safety Expert
For Food Professionals

As of July 3rd, the Food and Drug Administration (FDA) will have increased authority to use administrative detention as an enforcement tool. For this reason, companies that manufacture, prepare, pack or hold food should ensure strong record keeping practices. Under the current criteria of the Food Drug and Cosmetics Act, the FDA may order the detention of human or animal food where there is credible evidence or information indicating an article of food presents a threat of serious adverse health consequences or death to humans or animals.

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Did You Know?

RAPS Annual Conference and Exhibition
October 23-26, 2011, Indianapolis, IN

BARQA 3rd Annual Global Conference
November 13-16, 2011, Bristol, England

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Did you know that the FDA has recently introduced a new strategy for ensuring the safety and quality of imported products? If your company or organization is subject to FDA regulations, it's important to know that this month marks the introduction of some new and important changes at the FDA.
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