FDA Inspections: Sponsors and Your Sites

Why do you care, only the "big guys" are inspected?
Any sponsor and any site can be inspected by FDA. FDA might start by looking at another trial, then turn its attention to you because you use the same investigator. How do you protect yourself?

Noted attorney Steve Schurr will carefully examine:
1) What triggers FDA inspections.
2) What you should have in place before you even hear there will be an inspection.
3) What you should do as soon as you hear there will be a site inspection.
4) What you should do as soon as you hear there will be a sponsor inspection.
5) What are 483s and inspection reports.
6) Do inspections always lead to warning letters?
7) What are the consequences of inspections and warning letters?
8) Can sponsors be blacklisted like investigators?
9) What are a CRO's liabilities.
10) What happens to your trial if your IRB fails an inspection.

CDG is committed to rich-content events. You will receive:
1) PowerPoint slides.
2) Sample SOP for preparing sites for inspections.
3) Sample SOP for preparing sponsors for inspections.
4) Flowchart of the inspection process.
5) Example warning letters showing common problems with device trials.
6) Spreadsheet of problems found by FDA.
7) CEUs and Certificate of Attendance.

Who should attend:
Sponsors, monitors, investigators, coordinators, and CROs who care about best practices for medical device clinical trials.

Presenters:
Mr. Steven C. Schurr, Esquire, as presenter, has practiced medical device law for 13 years, was regulatory affairs professional prior to becoming a lawyer, has himself been inspected by the FDA as a sponsor, and has assisted clinical trial sponsors in FDA audits of investigational sites. You can read more about Mr. Schurr at http://www.steveschurr.com

The purchase is $400 for the CD. Event materials are available on the CD itself. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.