Why Should You Attend:

The field of GCP has rapidly evolved over the last few years and the requirements are getting tougher. Many companies find themselves unprepared for a clinical trial audit, either at a clinical site or their headquarters. One of the important aspect of managing a clinical trial is drug accountability.

An FDA inspector once said that any individual should be able to perform drug reconciliation at an investigative site within 20 minutes. When drug accountability records are well designed and error-free, and appropriately reconcile from initial shipment to the site through final disposition, this statement should hold true.

This course will help you to prepare early and help to prevent surprises when being audited. Learn to efficiently manage drug accountability. This program will also share the ”audit experience”, by sharing what auditors look for in term of drug compliance and accountability and how to prepare for the visit. This webinar will describe proactive measures you can take to assure that all systems are in place, operating well and operating in compliance..

Areas Covered in the Seminar:

- Investigational Drug Shipment.
- Drug accountability at the investigative site.
- Documentation in Key to accountability.
- Ensuring Compliance and reconciliation.
- Corrections.
- Monitors.
- Drug Return or destruction.
- What auditors observe?
- FDA inspection findings- Warning letters.