How to Monitor Pharmaceutical, Biologic and Medical Device Clinical Trials for GCP Compliance
Training Course - Los Angeles, CA
By the end of this course, participants will have a detailed understanding of how to:
Identify and define the principles and requirements for GCPs
Define the roles and responsibilities of sponsor, monitor, investigators and FDA as they relate to the quality of clinical trials
Recognize clinical trial documentation differences for drug, device, and biologic studies
Recognize how GCPs can impact clinical research programs
Put into practice the regulatory, source documentation and record-keeping requirements for clinical trials
Understand what happens during a GCP inspection
Detect and prevent fraud and misconduct in clinical trials
Ensure that your data and supporting documentation are accurate and in the right format for inspectors
This training course provides a solid understanding of GCP requirements and a clinical compliance overview for clinical trials. Attendees will gain experience in proven techniques for detecting, correcting and preventing clinical study deficiencies at domestic and international clinical sites. This course teaches you how to ensure that your data and supporting documentation are completely accurate, factual and in the appropriate format for company and regulatory authorities. Included in the course work are practical examples and a roadmap for evaluating SOPs, consent forms, investigator brochures and source documents through presentation and interactive case studies.
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23rd - 24th July 2012
The Hilton Los Angeles Airport (LAX)
5711 West Century Blvd., Los Angeles, CA 90045, United States
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