Agile Intro for Regulated Medical Software Business and Regulatory Impacts This introductory course, intended for managers, quality, regulatory, and other roles in addition to software development, presents the information you need in order to plan your transition to an Agile approach. Whether you are brand new to Agile, or have tried Agile and found your approach isn’t giving the hoped-for results, this course will fill in what you need to know. Instructors Nancy Van Schooenderwoert and Brian Shoemaker have presented multiple workshops and courses to medical device audiences since 2009. They combine depth of experience in the Agile and engineering fields: hardware and software development, Agile coaching, regulated software for medical products, software quality, regulatory concerns, documentation, risk management. Course details The Agile approach is well established in other industries, and adoption of Agile in medical device development has been increasing in the past five years. Experience is showing that Agile teams achieve higher quality and safety than before, while still meeting regulatory requirements. By walking through a safety critical project, Nancy Van Schooenderwoert and Brian Shoemaker delve into several key areas for applying Agile methods in the medical device context, including: Countering myths and preconceived ideas about Agile methods Understanding the REAL regulatory requirements Agile is a mindset, not a canned method How to choose an Agile pilot project Agile in hardware and software development Applying Impact Mapping and Story Mapping practices to chart the way How to move from traditional specs to Agile stories Bringing everyone on board, not just software Applying Agile in larger organizations / projects Metrics – how to use them; what to avoid! Rather than focus on any methodology (e.g. Scrum, Kanban, Crystal, XP), this course aims to build understanding of the fundamentals which underlie all Agile methods, so that teams can determine their own blend based on what works in their context, and address the issues which inevitably come up in Agile adoption. Practical illustrations will be demonstrated by use of specific tools, but the tools themselves are not the focus. Interactive exercises reinforce what you learn, as you get to know colleagues in other companies. You won’t be struggling to stay awake! Who should attend? Regulatory specialists Functional managers – Software, Test, Hardware Product / Project managers Technical leaders Business Analysts, Requirements Analysts This will be an introductory course, and makes no assumptions about previous knowledge or experience with the Agile approach. Course Instructors Nancy Van Schooenderwoert 15 y safety-critical embedded systems development experience, as Electronics and Software designer Agile coaching of teams & managers in regulated industries since 2002 Industries: Aerospace, Medical Devices, Sonar Weaponry, Scientific Instruments, Industrial Controls, Financial Services Active in Agile New England & Agile Alliance; speaker at Agile-related conferences worldwide Brian Shoemaker Originally an analytical chemist 15 y in clinical diagnostics: analysis support – assay development – instrument software validation 6 y as SW quality manager (5 in clinical trial related SW) 14 y as independent validation consultant to FDA-regulated companies – mostly medical device Active in: software validation, Part 11 evaluation, software quality systems, auditing, training Here’s what course attendees are saying… “We are about to start using Agile and we were attending SDMD [Software Design for Medical Devices conference], so it was the perfect moment and the right training.” – Ramon Alonso, Software & Communication Engineer, Kiro Grifols “As a leader/manager in the organization, the course has been great to have a broader understanding of the Agile mindset.” – Rebecca Stead, Sr. Vice President – Operations & Development, STRATEC Biomedical UK, Ltd. “I find the workshop you give very easy to follow and I appreciate the references also. Every year I pick up on some new things to try and take back to my teams.” – Grayson Marpes, Director, Compliance and Governance, Infor Course Format – Full Day 8:30 – 9:00 Check-in, coffee and light breakfast 12:00 – 1:00 Lunch break – Selection of items available and included in course fee 5:00 pm – Course complete! Includes: Lunch, plus morning and afternoon breaks with refreshments Wi Fi connectivity Free parking Book included in your Course fee: «Agile Methods for safety-Critical Systems» Questions? You can contact us with any further questions you may have. Email: orderinfo@leanagilepartners.com Phone: 781 492 5376 (cell) Cancellation Policy Cancellation by course organizers would only occur in the unlikely event of insufficient registration. If the course is cancelled, we will notify you no later than Jan 8, 2020, and refund your payment in full. We cannot be responsible for non-refundable travel expenses you incur. If you’d need to travel to attend and are concerned about possible cancellation, please contact us at orderinfo@leanagilepartners.com and we will let you know if we’ve passed the minimum required attendance. FAQs What are my transportation/parking options for getting to and from the event? The site has a very large outdoor parking lot. Parking is free. The area is best reached by car. What can I bring into the event? Your laptop is good to bring although it’s not required to participate in the course. How can I contact the organizer with any questions? Email: orderinfo@leanagilepartners.com Phone: 781 492 5376 (cell) What’s the refund policy? Jan 8, 2020 is the last day to request a refund. You may cancel after that date but no refund can be given. Cancellation by course organizers would only occur in the unlikely event of insufficient registration. If the course is cancelled, we will notify you no later than Jan 8, 2020, and refund your payment in full. We cannot be responsible for non-refundable travel expenses you incur. If you’d need to travel to attend and are concerned about possible cancellation, please contact us at orderinfo@leanagilepartners.com and we will let you know if we’ve passed the minimum required attendance. Do I have to bring my printed ticket to the event? It is helpful to bring your ticket, but it’s ok to have identification that matches the name given when the ticket was bought. Is my registration fee or ticket transferrable? Yes, if you tell us in advance. Please use email. Email: orderinfo@leanagilepartners.com Is it ok if the name on my ticket or registration doesn’t match the person who attends? Yes, if you tell us in advance. Please use email. Email: orderinfo@leanagilepartners.com