Nancy Van Schooenderwoert – Lean Agile Partners
Nancy is President and Principal Coach at Lean-Agile Partners. She was among the first to apply Agile methods to embedded systems development. As an engineer, manager, and consultant, she has led Agile change initiatives for software and hardware projects in safety-critical, highly regulated industries, including aerospace, factory automation, medical devices, defense systems, and financial services.
Nancy teaches modern Agile approaches like Mob Programming, Agile Hardware, and Lean development methods, in addition to Scrum. She is a past president of Agile New England, and has led numerous ANE events, including the Agile for Executives event series, Deep Agile and Mob Programming conferences. Nancy is a regular presenter at Agile-related conferences worldwide, and is co-author of the book “Agile Methods for Safety-Critical Systems: A Primer Using Medical Device Examples”, published in 2018.
Follow Nancy on Twitter at @vanschoo
Brian Shoemaker – ShoeBar Associates
About ShoeBar Associates
Principal Consultant: Brian Shoemaker, Ph.D.
- More than 20 years’ experience with software quality and validation in the FDA-regulated industry.
- Knowledgeable in diverse application areas, including automated in vitro diagnostics, clinical trial data management, clinical safety data, ERP and shop floor automation, change order management, and electronic document management.
- Well versed in practical application of FDA and ISO requirements for software life cycle documentation, validation, and risk management.
- Adept at unraveling issues around electronic records and signatures (21 CFR Part 11).
- Diverse clientele, including manufacturers, software developers, medical device startups, and pharmaceutical multinationals.
- Fluent in German
ShoeBar Associates is committed to helping our clients establish software quality and control, to achieve regulatory compliance, world-class product reliability, and unquestioned patient and user safety.
Follow Brian on Twitter: @brian_shoe