MDRM 2013 Agenda
Beyond FMEA — New Tools To Assure Your Risk Management Program Meets New Standards
Agenda
DAY ONE |
|
8:00 a.m. – 9:00 a.m. |
Registration and 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. |
INTERACTIVE EXERCISE |
11:00 a.m. – 11:30 a.m. |
The Regulatory Structure: The Current Status of ISO 14971:2007
|
11:30 a.m. – 12:00 p.m. |
Understanding ISO 14971:2007 (Part 1)
|
12:00 p.m. – 1:00 p.m. |
Lunch Break |
1:00 p.m. – 1:30 p.m. |
Understanding ISO 14971:2007 (Part 2)
|
1:30 p.m. – 2:30 p.m. |
Building a Risk Management File That Meets ISO 14971:2007 Requirements (Part 1)
|
2:30 p.m. – 2:45 p.m. |
Break |
2:45 p.m. – 3:45 p.m. |
INTERACTIVE EXERCISE |
3:45 p.m. – 4:30 p.m. |
Building a Risk Management File That Meets ISO 14971:2007 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. – 10:00 a.m. |
INTERACTIVE EXERCISE |
10:00 a.m. – 12:00 p.m. |
Digging Deep Into the Risk Management Tool Kit
|
12:00 p.m. – 1:00 p.m. |
Lunch Break |
1:00 p.m. – 2:30 p.m. |
APPLICATIONS IN THE EUROPEAN UNION
|
2:30 p.m. – 2:45 p.m. |
Break |
2:45 p.m. – 4:15 p.m. |
Related Standards
|
4:15 p.m. – 4:30 p.m. |
Summary, Conclusions, and Lessons Learned |
4:30 p.m. |
Adjourn Workshop |