Clinical Quality Assurance 2012 Agenda
DAY ONE |
|
8:00 a.m. – 8:30 a.m. |
Registration and Continental Breakfast |
8:30 a.m. – 10:00 a.m. |
Starting on the Same Page: Good Clinical Practice Regulatory Requirements and Expectations
|
10:00 a.m. – 10:15 a.m. |
Break |
10:15 a.m. – 12:00 p.m. |
GCP Audits: What Audits Are Needed to Maintain a Compliant GCP Program
|
12:00 p.m. – 1:00 p.m. |
Lunch Break |
1:00 p.m. – 3:00 p.m. |
Working With a CRO: Conducting Compliant GCP Studies
|
3:00 p.m. – 3:15 p.m. |
Break |
3:15 p.m. – 5:00 p.m |
Most Commonly Cited GCP Violations at a Clinical Site
|
5:00 p.m. |
Session Wrap-Up, End of Day 1 |
DAY TWO |
|
8:00 a.m. – 8:30 a.m. |
Continental Breakfast |
8:30 a.m. – 10:30 a.m. |
Writing GCP Audit SOPs: Elements of the SOPs
|
10:30 a.m. – 10:45 a.m. |
Break |
10:45 a.m. – 12:00 p.m. |
Preparing And Setting Up CQA Audits
|
12:00 p.m. – 1:00 p.m. |
Lunch Break |
1:00 p.m. – 5:00 p.m. |
5 Tools For CQA Auditors
|
5:00 p.m. |
Workshop Adjourns |