Gain a working understanding of Good Clinical Practices (GCP) regulations, the GCP quality assurance process, and GCP concepts that will help you design and manage studies.





WHAT YOU WILL LEARN

Principles of Good Clinical Practices (GCP)
Audit programs and strategies
Role of the audit
GCP documentation and regulations
Audit preparation and follow-up
Drug accountability and computer systems
Fraud and misconduct


Learning Objectives:

At the conclusion of this course, participants should be able to:

Discuss current issues and problems in the implementation of GCP regulations
Apply principles of GCP to the conduct of clinical trials in the US and other countries
Manage GCP documentation to ensure regulatory compliance
Strategically plan, prepare for, and organize an FDA GCP inspection
Recognize the various types of clinical trial fraud and misconduct and the ramifications
Describe the quality assurance audit process


Target Audience:

Clinical research associates
Quality assurance auditors
Data management professionals
Medical writers
Regulatory affairs professionals

Event Code:
10447