Clinical Compliance 2011 - FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program

This FDA Clinical Trial Auditing training will cover the FDA regulations and the ICH GCP recommendations to ensure your site is prepared for a clinical trial audit.

Why Should You Attend:

There is an increasing frequency of real-time FDA Audits of trials and it seems that no one is well prepared. It is reasonable to expect that the Sponsor’s Monitors would be invaluable to the Site, CRO and even the Sponsor themselves to find errors and mistakes and correct as well as prevent their future occurrence.

Areas Covered in the Seminar:

- What does the FDA look at when Auditing/Inspecting a study?

- The Sponsor‘s responsibility in monitoring study conduct.

- Components of a sponsor monitoring system beyond SOPs.

- The nature of adequate oversight of all staff and non-staff.

- The importance of Protocol knowledge in preventing errors.

- How do sites prepare for an audit / inspection.

- The measures to ensure quality monitoring..

NOTE : Use this Promocode (128600) to avail 10% discount, valid upto 14th December 2011.