This seminar provides an overview of the structural elements of Good Clinical Practice (GCP). Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to how quality systems, or a lack thereof, impact overall data quality and regulatory risk. This seminar is designed for professionals with at least two years of experience in the clinical research industry.
- Describe the elements of a functional Quality System
- Examine recent trends in non-compliance
- Discuss the role of SOPs in GCP
- Characterize the differences between the legal and procedural elements of GCP
- Recognize key differences in pharmaceutical, device, and biologics GCP
- Clinical Quality Assurance Professionals
- Clinical Research Associates
- Project Managers
- Investigators
- Study Coordinators
- GCP-Focused Regulatory Affairs Professionals
Elizabeth Ronk Nelson, MPH
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2 hours; 1:00 - 3:00 p.m. Eastern
August 24, 2010
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471