Agile Next Steps for Regulated Medical Software, The Centres at Burlington, Thursday, 16. January 2020

Agile Next Steps for Regulated Medical Software
Your company has accepted the concepts of Agile and you’ve started one or more projects which use the approach. You’re making good progress, but you want guidance on getting the most out of this new method. In particular, you’re looking for how to document your project, how to address risk management, how to coordinate hardware and software efforts, and how to work in human factors engineering (none of which classically seems to fit the Agile mindset).
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
Picking up the thread from the introductory course, this session explores topics essential to any regulated medical product company applying an Agile approach for development. You’ll come away with a deep understanding of ways to avoid the false dichotomies that pit expediency against larger business needs - you’ll see how actions at the team level can improve overall flow of the work, and keep technical complexity from crippling later progress. You will also learn practical ways to address special needs of medical device work (such as documentation, risk management, hardware, or human factors...) without sacrificing any of the benefits Agile brings. 
 
Topics Covered:

Lean Flow in a Medical Device Example
Handling Complexity
Applying Agile Beyond Software
Documentation in Agile
Risk Management within Agile
Where does Human Factors Engineering fit?
Agile Leadership and the Organization

Each topic is reinforced through interactive exercises that all attendees can participate in, and most can be brought back to your workplace and used with the rest of your team members.   Our focus is on the core principles and practical ways to use them rather than on any one Agile methodology or framework. Our approach is compatible with Scrum, XP, and other Agile methods, and is based on experience working with a variety of medical device teams.
Who should attend?

Regulatory specialists
Functional managers - Software, Test, Hardware
Product / Project managers
Technical leaders
Business Analysts, Requirements Analysts

This is an intermediate course, and makes an assumption that attendees have either attended our introductory course, or have been involved in their company’s Agile adoption program for at least 6 months.



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…
“One of the best courses I’ve been on. Great combination of theory, exercise, and personal accounts…. Brilliant. I now have something to take back to Oxford. Thanks!”
   - John Garratt, Analyst, Mirada Medical 
 
“The delivery technique is excellent (e.g. the presentation slides, activities, team discussions, play games, powerful questions, etc.). Thanks.”
   - Wenjin Li, Medical Device QA Mgr
 
“The exercise of moving the tasks from dept to dept and to ‘Ship It’ was a great example and really gave us some ideas we can use to help explain the idea to non-dev management. Plus ... it wakes everyone up.”
   - 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



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 9, 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 9, 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

Thursday, 16. January 2020, The Centres at Burlington, Agile Next Steps for Regulated Medical Software

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