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2009 Clinical Research Workshop

How to Build Quality into your Program for a Food and Drug Administration (FDA) Audit

UT Southwestern Medical Center
T. Boone Pickens Biomedical Building
NG3.112 Auditorium

Schedule

Tuesday, May 5, 2009

7:30 to 8:00 a.m.
Registration

8:00 to 9:30 a.m.
GCP documentation

9:30 to 10:00 a.m
Break

10 to 11 a.m.
Human Subject Protection

11 to noon
Collecting, Managing and Reporting Data

noon to 1 p.m.
Lunch (provided).

1:00 - 2:00 p.m.
Audit Preparation.

2 to 3 p.m
The Audit Process and What to expect

3 to 3:15 p.m. Break

3:15 to 4 p.m.
Audit Findings Outcomes and Consequences

Q&A and wrap up

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For more information regarding the workshop, please call 214-456-1865 or email the workshop coordinator.

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