Good Clinical Practice (GCP) is an international quality standard that is provided by International Conference on Harmonisation (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.If you're looking for some education and training regarding GCP, then take a look at this upcoming course where you'll learn more about GCP. Here's a brief description:
This course provides an advanced, in-depth review 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 program is designed for professionals with at least two years of experience in the clinical research industry.
This course is recommended for experienced Clinical Quality Assurance Professionals, Clinical Research Associates, Project Managers, Investigators, Study Coordinators, and GCP-Focused Regulatory Affairs Professionals.
- Develop and implement site-specific approaches for corrective action of non-compliance
- Describe the elements of a functional Quality System
- Define key GCP terms
- Examine recent trends in non-compliance
- Identify the universal and local components of GCP
- Explain the differences between the legal and procedural elements of GCP
- Recognize key differences in pharmaceutical, device, and biologics GCP
- Describe the overlap between GCP and GMP
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