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March 16th Dinner Meeting |
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Best practices for Software Validation in today’s regulated environment Jeb Bullis, Amadeus Solutions Register by Noon Monday, March 13th, 2006 Your organization's definition of validation and how you achieve compliance is likely to be different than your competitors. The FDA defines validation as "… establishing documented evidence which provides a high degree of assurance that a specific process will produce a product meeting its pre-determined specifications and quality attributes…". Software validation goes beyond the simple execution of a set of pre-defined test scripts. It represents the very essence of software quality assurance.We will explore best practices of software validation and provide clear guidelines of the elements and process to validate and deploy web technologies in today's regulated environment.
About Our Speaker Mr. Jeb Bullis has a 21 year achievement of sales and consulting for integration of complex technology solutions, encompassing direct experience with FDA software validation of compliance and quality systems. For the last 11 years, Jeb has focused on bringing Web based technology improvement to manual corporate systems. He was a driving force in developing compliance and training programs for many manufacturing, financial and life sciences companies. A proud Badger from the University of Wisconsin, he now lives with his family in the Twin Cities, Minnesota. He is currently employed at Amadeus Solutions, the leading Compliance Process Control company. |