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Abstract

When It Just Has to Work: Agile Development in Safety-Critical Environments

Traditional thinking holds that the more critical the intended application, the more tightly its development must be planned, staged, and controlled. Only recently have some groups begun to apply iterative learning methods in regulated, safety-critical environments; their experience is that major shifts in thinking are necessary in such areas as planning, team interactions, and risk management. When the culture CAN shift, however, the result is not just that teams can achieve their goals sooner, but often that the product is safer and more robust.

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About the Speakers

Nancy Van Schooenderwoert
Nancy Van Schooenderwoert

Nancy Van Schooenderwoert is an Agile Enterprise coach and founder of Lean-Agile Partners, Inc. She has over a decade of experience applying Agile practices as an engineer, manager, and consultant. She shows executives how to apply Agile and Lean principles to all their business process, not just software development. She has led Agile change initiatives in safety-critical, highly regulated industries, and coached clients in the art of Agile technical and management leadership. Nancy's experience spans embedded software and hardware development for applications in aerospace, factory automation, medical devices, defense systems, as well as financial services.

She holds a bachelor's degree in Computer Engineering from Rochester Institute of Technology and is a contributor of articles and advisories for the Cutter IT Journal. Nancy has edited a column for the Agile Times, and served on the IEEE 1648 committee to define a standard for customers of agile teams. She has been a regular presenter at various Agile-related conferences since 2003, and also at the Embedded Systems conference. Her work in applying Agile methods to embedded systems has been referenced by Jim Shore and Mary Poppendieck in their recent books. She speaks at numerous software professional gatherings worldwide, and is currently active on the board of Greater Boston's premier agile user group, Agile Bazaar.

Website: http://www.leanagilepartners.com

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Brian Shoemaker
Brian Shoemaker

Brian Shoemaker provides consulting services and training in computer system validation, software quality assurance methodology, and electronic records and signatures. He has been responsible for validation of software in a variety of FDA-regulated settings, from the embedded applications driving immunodiagnostics instruments to custom applications for clinical-trial data management. He has also designed and instituted quality systems for software development. Brian is Principal Consultant for ShoeBar Associates; previous positions include Quality Assurance Manager at PPD Informatics (now CSS Informatics), QA/Validation for Doxis, Inc., and Systems Engineering Manager at Behring Diagnostics, Inc. Brian earned his Ph.D. in chemistry from the University of Illinois; he has achieved the ASQ Software Quality Engineer certification.

Website: http://www.shoebarassoc.com


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