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Introduction to Good Clinical Practices and Auditing

 
  June 04, 2011  
     
 
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

 
 
Organized by: DIA
Invited Speakers: See website for speaker information
 
Deadline for Abstracts: Call contact
 
Registration:

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

E-mail: colleen.buckley@diahome.org
 
   
 
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