Drug Information Association, Inc, Horsham, PA USA
Oct 26 2011 9:00AM - Oct 28 2011 4:00PM
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. 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
Event Code: 11420
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