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34594 Conferences

Implementing a Quality Systems-Based Approach to GCP Compliance - Webinar By GlobalCompliancePanel

Added by davidross759 on 2011-08-26

Conference Dates:

Start Date Start Date: 2011-09-13
Last Date Last Day: 2011-09-13
Deadline for abstracts/proposals Deadline for abstracts/proposals: 2011-09-13

Conference Contact Info:

Contact Person Contact Person: webinar
Email Email:
Address Address: online training webinar, Wilmington, DE, 19801, United States
Phone Tel: 800-447-9407
Phone Fax: 3022886884

Conference Description:

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
Who Will Benefit:
Study Coordinators
Principle Investigators

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
Phone: 800-447-9407
Fax: 302-288-6884
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