Key Aspects of the Trial Master File and How to Pass FDA Inspection - Webinar By GlobalCompliancePanel 2011

Topics

• Role and responsibilities of clinical trial staff
• ICH guidelines and Good Clinical Practice (GCP)
• Understanding compliance
• Key aspects of the Trial Master File
• Audit preparation
• Most frequent audit findings
• Developing a CAPA
• Responding to audit findings

Key Aspects of the Trial Master File and How to Pass FDA Inspection brings together CROs Study Team / Study Managers, Clinical Trial Sponsors Study Team, CRAs, Clinical Team Leads, Site Managers and Study Coordinators, Principal Investigators, New Principal Investigators, New Clinical Research Coordinators, Regulatory Compliance Associates and Managers.