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Featured Articles

July 2011

David Dills

Writing and Enforcing Your SOPs for GxP Compliance Success

by David Dills
Quality & Compliance Advisor

"Say what you do, do what you say and be able to prove it."

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.

Typical definitions include the procedures and processes that you utilize and operate under. These procedures and processes have been standardized to ensure they are done the same way every time. A "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function."

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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.

Unfortunately, there is no clear, black and white answer. There are many complex factors. The need for such credentials depends on the job, the company, the interviewer or person screening the resumes, etc. In the end, it probably comes down to this: having certifications and advanced degrees certainly will not hurt your chances of finding a job or advancing in your profession. However, those who believe that certification or an advanced degree is the key to finding employment in a competitive job market will be sorely disappointed.

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

Quality Event Management CAPA Workshops
August - 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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Did you know that you could receive detailed, FREE training from FDA CDRH Learn? For the medical device industry, it's not always easy to understand and correctly implement FDA regulations. CDRH (Center for Devices and Radiological Health) is providing a free online educational tool with training modules that describe "many aspects of medical device and radiological health regulation [that cover] both premarket and postmarket issues."
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