Introduction to Good Clinical Practices and Auditing

Date(s) And Time(s):
Oct 26 2011 9:00AM - Oct 28 2011 4:00PM

Drug Information Association, Inc.
800 Enterprise Rd Ste 200,
Horsham, PA 19044-3509

Apply Good Clinical Practices to ensure compliance.

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.


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:

Contact Information:

For detailed program information including faculty and topics, please contact:
Colleen Buckley
Tel. +1-215-442-6108
Email Course