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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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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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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Implementation of Food Safety Modernization Act by Cathy Crawford HACCP and Food Safety Expert

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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