Palo Alto, CA -- (SBWIRE) -- 10/14/2009 -- This Clinical Trial Audit webinar / training is designed to provide information on the importance of having an audit plan in place for clinical trials to be submitted to the FDA. Development of an independent audits/data verification and compliance monitoring program will be discussed.
Areas Covered in the seminar:
Key factors of any quality assurance program.
What audits should constitute an audit program for clinical trial sites.
Audit plan details.
Recommendations regarding site selection for audit, audit activities, audit frequency, trending of audit data, identification of quality issues and risks.
FDA Inspection program for clinical trial sites.
Most Common FDA findings from clinical site inspections.
How to use trended data from audits and common FDA findings to ensure audit program will identify these issues.
Who will benefit:
This webinar will provide valuable assistance to all personnel in:
Research facilities conducting clinical trials
Quality Assurance Personnel
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