Course Description

This application-based web seminar covers advanced concepts and challenges encountered in the application of Good Clinical Practice (GCP). During this highly interactive course, participants will review and discuss cases that include GCP challenges in topic areas such as IRB/IEC approval, informed consent, drug accountability and reconciliation, SUSAR submissions, communications with ethics committees and health authorities, as well as the management of investigational product. Cases are based on actual industry examples, and participants are expected to solve cases by applying Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) principles, which are briefly reviewed.

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Learning Objectives

• Apply your understanding of the GCP standards most critical to core clinical research job functions
• Explain the role of Quality Systems in the GCP environment
• Apply GCP through critical thinking in the context of real-world clinical research scenarios and simulations
• Explain the concepts of RCA and CAPA to improve site and sponsor performance and compliance

Who Should Attend

• Clinical Quality Assurance Professionals
• Clinical Research Associates
• Project Managers
• Investigators
• Study Coordinators
• GCP-focused Regulatory Affairs Professionals
• Clinical Operations Professionals

Instructor

Janet Ellen Holwell, C.C.R.C., C.C.R.A.

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