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.
- 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
- Clinical Quality Assurance
Professionals
- Clinical Research
Associates
- Project Managers
- Investigators
- Study Coordinators
- GCP-focused Regulatory
Affairs Professionals
- Clinical Operations
Professionals
Janet Ellen Holwell, C.C.R.C., C.C.R.A.
Click here for complete trainer
biographies
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.