MDRM2010Agenda
DAY ONE |
|
8:00 a.m. – 9:00 a.m. |
Registration/Continental Breakfast |
9:00 a.m. – 10:15 a.m. |
Workshop Introduction and Concepts of Risk Management Overview
|
10:15 a.m. – 10:30 a.m. |
Break |
10:30 a.m. – 11:00 a.m. |
The Regulatory Structure: The Current Status of ISO 14971:2007 and Beyond
|
11:00 a.m. – 12:00 p.m. |
Understanding ISO 14971:2007
|
12:00 p.m. – 1:00 p.m. |
Lunch Break |
1:00 p.m. – 2:30 p.m. |
Building a Risk Management File That Meets ISO Requirements
|
2:30 p.m. – 2:45 p.m. |
Break |
2:45 p.m. – 4:30 p.m. |
Building a Risk Management File That Meets ISO Requirements (Part 2)
|
4:30 p.m. |
Session Wrap-up, End of Day One |
DAY TWO |
|
8:30 a.m. – 9:00 a.m. |
Continental Breakfast |
9:00 a.m. – 10:30 a.m. |
Digging Deep Into the Risk Management Toolkit
|
10:30 a.m. – 10:45 a.m. |
Break |
10:45 a.m. – 12:00 p.m. |
INTERACTIVE EXERCISE! Applying Risk Management Tools in Real World Situations — Attendees will be given the opportunity to work together and with the presenter to use risk management tools in a collaborative setting. There is an exercise for each tool, but participants can choose the one or two tools that best apply to their concerns. |
12:00 p.m. |
Adjourn Workshop |