Meeting Archive
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 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 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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