Agile 4 FDA: The Lean-Agile Solution
May 17, 2013
Burlington, MA (in Greater Boston area)
Contact: Judy Isaacson | Link to Event
Course Overview:
Are FDA software quality and validation dragging down your development effort? Of course we have a safety responsibility to patients and caregivers who will use our product, as well as a responsibility to our managers and our investors to get a usable product out the door on time and within budget. And 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 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, including:
- Managers
- Team leaders and technical leads
- Software Developers
- Requirements analysts and business analysts
- Validation and Quality Assurance personnel
What you will learn
- Overview 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 software
- How Agile development improves speed and quality without losing FDA compliance
Can't attend on this date or place? Consider bringing this course in-house at your company. Contact us for details - nancyv@leanagilepartners.com We offer this course or simmilar courses regularly in Europe. The most recent run was January 31 as part of SDMD conference in Munich. The next run will be in June 2013 as part of the XP2013 conference in Vienna during the first week of June.