US GCP Fundamentals for Pharmaceutical and Biologic Companies 2017

Topics

• Which FDA regulations constitute GCP
• The meaning of the term Good Clinical Practice (GCP)
• The basic elements of informed consent
• The requirements the regulations place on Sponsors, CROs, clinical trial sites and IRBs
• The applicability of Good Manufacturing Practice to the production of clinical trial materials
• The rules for avoidance of financial conflict of interest by clinical investigators
• The criticality of data integrity and the prevention and detection of fraud and misconduct in clinical trials
• Why inventory control and reconciliation is important to GCP compliance
• The role of ICH guidelines in GCP compliance
• The basics of FDA inspection manage ment, and how to find key guidance resources to prepare for and manage FDA GCP inspections

Who should Attend

• Clinical QA Staff
• Clinical Operations Staff
• CRO Employees involved in the above areas
• Clinical Research Associates
• Clinical Auditors
• Regulatory Affairs professionals
• Clinical trial site coordinators
• GMP Professionals who need to understand GCP requirements