Course Description

An audit is defined as a systematic and independent examination of trial-related activities and documents. Beyond the review of documents and interviews, auditors are tasked with using factual, objective evidence to support conclusions regarding compliance and assessing whether proposed interventions are acceptable to effectively address the underlying concerns. Utilizing real-life examples and information, participants will work individually and within a group of their peers to review material, assess significance of findings, determine whether or not compliance issues exist, and develop plans for efficient compliance solutions. This interactive web seminar will allow participants to further develop auditing skills.

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Learning Objectives

• Discuss current Good Clinical Practice (GCP) compliance issues
• Assess patterns in data using data trend analysis
• Review information for accuracy and validity
• Perform root cause analysis for a study scenario and develop a corrective and preventive action plan (CAPA), including impact assessment to facilitate review of intervention

Who Should Attend

• Clinical Quality Assurance Professionals
• Auditors
• Project Managers
• Clinical Investigators
• Clinical Operations Professionals
• Personnel responsible for ensuring compliance with Good Clinical Practice (GCP) regulations

Instructor

Elizabeth Ronk Nelson, M.P.H.

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.