Agile 101 for Oct 06, 2016 - two sessions
Topic: Agile for Developing Medical Devices
For medical device development, Agile methods of planning and organizing work, and typical Agile technical practices, are necessary but not sufficient. Several other key activities are essential in the FDA regulated realm.
Led by Brian Shoemaker
Brian Shoemaker, Ph.D., is the Principal Consultant at ShoeBar Associates. He has more than 20 years’ experience with software quality and validation in the FDA-regulated industry. Brian has conducted validation both on product software and on internal software, developed software quality systems, audited software quality processes (including agile methodology), and evaluated 21 CFR Part 11 compliance. Previous to founding ShoeBar Associates, Brian had quality roles at PPD Informatics, Doxis, Inc., and Behring Diagnostics, Inc. Brian earned his Ph.D. in chemistry from the University of Illinois; he has achieved the ASQ Software Quality Engineer certification.
Adonis El Fakih
Topic: Scrum 101
In this session we will take a general walkthrough of Scrum and how it aligns with Agile values and principles. This overview will set the stage for deeper exploration in the ensuing sessions.
Led by Adonis El Fakih
Adonis El Fakih is an entrepreneur, software executive, consultant and author. He is a founder and former CEO and CTO of several technology companies, and the author of Agile Stream Thinking, an Agile Management Approach to Accelerate Agile Adoption and Streamline Business Value Delivery. Adonis is Certified as CSP, CSM, CSPO, ICP, ICP ATF and ICP ACC.
Agile 101 and Kanban 101 courses run from 6:00 to 6:45 during the networking period
of the monthly meeting. A sign-up sheet is posted at 5:30 near the check-in table.
Capacity is limited to 10 people per class, and sign-up is first come, first served.