Research Affairs would like to invite you to the March 8 Lunch Seminar:
FDA Audit: Survival Report from the Trenches
If you are involved in any FDA-regulated research, you cannot afford to miss this presentation. The potential consequences of an unfavorable FDA audit make anything short of near-perfect compliance just not an option. Since the stakes are high and the stress can be intense, why not learn ahead of time from your own colleagues who sailed cleanly through that gauntlet?
Learn from them not only how to handle the audit itself, but even more importantly, how the actions you take during the preparation and conduct of the study have already pre-determined your fate on the day the FDA arrives at your door. On the other hand, everything the FDA expects are actually common-sense criteria for how to conduct clinical research in ways that have the potential to yield reliable study data, while preserving the safety and the rights of subjects in the process.
If you are a coordinator, bring your PI. If you are a PI, bring the key members of your study team. This is one you do not want to miss.
The program will be held in the Research Affairs main conference room from 12-1pm. Physicians attending this session will earn CME.
You must register to receive credit and so we can have lunch ready for you. Seating is limited.
Please click link Register
Also, attendees who submit an evaluation form after the program will be entered into a drawing for a $25 gift card. Congratulations to Richard Maxwell for winning the drawing for a $25 gift card at the last seminar.