This webinar will highlight the 21 most common FDA observations of noncompliance at investigator sites and how many of them relate directly to the sponsor's clinical research and clinical operations procedures. It will provide tools and procedures for preventing or remediating these observations of noncompliance.
Why Should You Attend:
Risk management is the operative system in the medical product development process. GCP Non Compliance at the investigator site remains the sponsor’s primary liability for the rejection of the regulatory application. Fifty percent of all FDA study related investigational site inspections incur some level of GCP noncompliance observations.
This course will demonstrate that many of the 21 most common FDA observations of noncompliance at investigator sites relate, not to the investigator, but directly to sponsor's clinical research and clinical operations procedures. We will examine how you can delegate sponsor regulatory responsibilities to a CRO through a brief discussion of three case histories. Many of these observations of noncompliance can be prevented or remediated if the impact of the sponsor procedures on the investigator’s conduct of the clinical is recognized and anticipated. The speaker will present tools for the evaluation and assessment of GCP noncompliance impact on the study data.
Added by complianceonlinecom on October 19, 2012