US GCP Fundamentals for Pharmaceutical and Biologic Companies 2017 is a seminar that covers topics such as:
- 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
US GCP Fundamentals for Pharmaceutical and Biologic Companies 2017 brings together:
- 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
