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[ANN] Agile Software Quality and FDA course, Boston Oct 4

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  • Nancy Van Schooenderwoert
    A live workshop in Medical Software Development using Lean-Agile Methods (visit http://www.meddevgroup.org/courses.htm for information and links for
    Message 1 of 1 , Sep 19, 2011
      A live workshop in Medical Software Development using
      Lean-Agile Methods

      (visit http://www.meddevgroup.org/courses.htm for information and
      links for downloadable flyer and to register)

      Date: Tuesday, October 4, 2011
      Agenda: 8:30 continental breakfast, 9:00 - 5:00 course,
      12:00 - 1:00 Lunch
      Location: 67 South Bedford Street, Suite 400 West,
      Burlington, MA 01803

      We who develop software for medical applications - medical device
      software and more - have a safety responsibility to patients and
      caregivers who will use our product, but also have a responsibility to
      our managers and our investors to get a usable product out the door on
      time and within budget. And of course we can't forget that we need to
      fulfill regulatory requirements!

      Many companies struggle with meeting all these expectations;
      software-related product recalls and failed companies are the legacy of
      traditional, sequential methods. In this one-day course, we present the
      basics of software quality for FDA compliance, then show how lean/agile
      development, properly applied, provides a solution to both high quality
      and high productivity.

      The morning session sets out an overview: where the FDA's concerns lie,
      what can be changed about traditional development while retaining good
      practices, and how development teams can be both fast and cost-
      effective. The afternoon session then delves in depth into each of the
      key areas of concern: standards and guidance, role of a quality
      management system, risk management as applied to software, agile
      project flow, agile planning and team autonomy, and approaches to
      documentation when using an agile approach.

      Join Tony Raymond, Brian Shoemaker, and Nancy Van Schooenderwoert as
      they present fundamentals of software quality for FDA compliance - with
      lean and agile principles to resolve quality/safety vs. cost/time.

      Who should attend:
      Product development personnel working on medical device software,

      * Managers
      * Team leaders
      * Software Developers
      * Quality Assurance personnel

      What you will learn:
      * background of the FDA regulations
      * Which FDA and international standards relate to device software -
      and what they REALLY say
      * What SOPs are needed in a good software quality system
      * How to apply hazard analysis / risk management to medical device
      * How Agile development improves speed and quality without losing FDA

      Nancy Van Schooenderwoert, Lean-Agile Partners Inc.

      781 301 1822 US mobile


      Specialties: Agile coaching for Embedded Systems, for Data Migrations,
      and for leadership of Lean-Agile change organization wide
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