Introduction to Good Clinical Practices and Auditing
Venue: Drug Information Association, Inc
Location: Horsham, Pennsylvania, United States
Event Date/Time: Nov 08, 2010 | End Date/Time: Nov 10, 2010 |
Description
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