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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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May 15, 2010 |
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Drug Information Association, Inc. , Horsham, PA
Nov 8 2010 9:00AM - Nov 10 2010 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
Target Audience:
Clinical research associates Quality assurance auditors Data management professionals Medical writers Regulatory affairs professionals
Event Code:
10447
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Organized by:
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Drug Information Association, Inc. |
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Invited Speakers:
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Call contact
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Deadline for Abstracts:
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Call contact
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Registration:
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For detailed program information including faculty and topics, please contact:
Colleen Buckley
Tel. +1-215-442-6108
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E-mail:
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Colleen.Buckley@diahome.org
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