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5th Annual FDA and the Changing Paradigm for HCT/P Regulation University of Rhode Island and Pharma Conference Las Vegas, NV, January 2009 Anita Richardson Associate Director for Policy Office of Compliance & Biologics Quality
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The FDA’s General Principles of Software Validation (GPSV), emphasizing how crucial requirements are to successful validation, recognizes the requirements for a successful validation project are difficult, if not impossible, to create accurately and to an adequate level of detail in one pass.
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As an IBM business partner and trusted advisor to over 100 FDA regulated companies and healthcare organizations, we have conducted more than 200 successful engagements through strategic partnerships that provide our customers with additional resources and value.
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The recent actions taken by the FDA against Baxter Healthcare Corp. illustrates the danger of having a quality system that is not in compliance with current FDA expectations for the company’s current business activities.
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Eight Pillars of an Effective Quality System
In the traditional compliance approach, Quality Assurance and Compliance are backroom cost centers, piling on non-value added requirements that detract from the company’s ability to innovate and be profitable.
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Root Cause Analysis is a method that is used to address a problem or non-conformance, in order to get to the “root
cause” of the problem. It is used so we can correct or eliminate the cause, and prevent the problem from recurring.
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