Why Should You Attend: Many GCP compliance programs focus too much on and "audit and correct" approach. FDA takes a systems base approach towards compliance and implementation of such an approach by the Sponsor, the CRO, and the Clinical Site increases the likelihood of maintaining an acceptable level of compliance. In this webinar you will learn to see GCP compliance as an interaction of several sub-systems the work together to ensure patient safety and ethical treatment.

Areas Covered in the Seminar:
Background for Clinical Trials and GCP (Good Clinical Practice)
The benefits of a Quality System approach
GCP Quality System
The Importance of the sub-systems: PI Oversight and Record Keeping; IRB Oversight; Monitoring; Clinical Staff and 3rd Party Qualification; IP Handling; Pharmacovigilance/Patient Safety
GCP Compliance Audits
Ranking the Severity of Observations
Resolutions of Deviations
References
Who Will Benefit:
Auditors
Study Coordinators
Managers
Directors
Principle Investigators

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884