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Featured Articles

July 2009

Why the "Band-Aids" Keep Falling Off

When we cut ourselves, we automatically reach for a Band-Aid®. Why? It stops the bleeding and we can quickly return to whatever we were doing before the accident happened. Root cause fixes can be applied a lot like Band-Aids; a quick solution to stop the bleeding and hope the problem solves itself. When the problem returns again or worsens, we realize that our quick fix might have backfired into something more. Peter Senge, author of "The Fifth Discipline Fieldbook," describes this as "Fixes that Backfire." His model depicts a two-cycle process. The cycle begins at the onset of a problem and we quick-fix (put on a Band-Aid) the problem.

The results will provide answers that form the basis of possible causes; not just the first one that comes to mind. Upon a closer look, these answers can be grouped into three levels.

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Designing a Winning CAPA System

CAPA is a critical Quality System subsystem that, when executed correctly, can provide your organization with a clear payback in terms of improved compliance, effectiveness and operational efficiency. So what is required of a CAPA system to make it compliant, effective and efficient in the United States, Europe, Canada or Japan?

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Regulatory Affairs Professional Society - Advanced Workshop for Preparing Compliant eCTDs
August 6-7, 2009, Rockville, MD

BARQA Annual Conference 2009
October 28-30, 2009, Brighton, UK

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Did you know that there is currently a bill before Congress that would require drug and medical device companies to report the payments, consulting fees, honoraria and other "transfers" worth over $100 they give to doctors every year?

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