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Wednesday, August 15 • 3:30pm - 5:00pm
Agile FDA Mini- Plays, Mosh Pit Style: Brian Shoemaker, Nancy Van Schooenderwoert

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In the FDA-regulated world, resistance to using Agile methods is still strong. We’ve turned several of the typical objections from quality and regulatory managers in the FDA-regulated industry into role-play sessions, both to explain the reason for the objection and to describe how well-managed Agile teams can answer it. By modeling the conversations you may need to have, we help you understand not just the FDA rules, but the thinking behind those rules. Our role play won’t be a “closed shop” – you can jump in too, and get your questions addressed!
http://submit2012.agilealliance.org/files/session_pdfs/Shoemaker_VanSchooenderwoert_Agile_FDA_MiniPlays.pdf

Speakers
avatar for Nancy Van Schooenderwoert

Nancy Van Schooenderwoert

President, Lean-Agile Partners, Inc.
Nancy was among the first to apply Agile methods to embedded systems development, as an engineer, manager, and consultant. She has led Agile change initiatives beyond software development in safety-critical, highly regulated industries, and teaches modern Agile approaches like Mob... Read More →
avatar for Brian Shoemaker

Brian Shoemaker

Principal Consultant, ShoeBar Associates
Brian Shoemaker consults for healthcare products companies in computer system validation, software quality assurance, and electronic records and signatures. He has conducted validation both on product software and on internal software, developed software quality systems, audited software... Read More →


Wednesday August 15, 2012 3:30pm - 5:00pm
Texas 3