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GCP Audits - Best Practices
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GCP Audits - Best Practices

This GCP training course provides a solid understanding of GCP requirements and clinical quality assurance in detecting fraud and misconduct in clinical trials. Attendees will gain experience in detecting, correcting, and preventing clinical study misconduct and fraud at domestic and international clinical sites.

7/29/2015 to 7/30/2015
When: July 29-30, 2015
Where: The Hilton Los Angeles Airport (LAX)
5711 West Century Boulevard
Los Angeles, California  90045
United States
Presenter: The Center for Professional Innovation & Education, Inc.
Contact: Olivia Carlin
610.648.7550

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GCP Audits - Best Practices for Ensuring Compliance & Detecting Fraud and Misconduct in Clinical Trials

This GCP training course provides a solid understanding of GCP requirements and clinical quality assurance in detecting fraud and misconduct in clinical trials. Attendees will gain experience in detecting, correcting, and preventing clinical study misconduct and fraud at domestic and international clinical sites.

Additionally, attendees will learn how to ensure that their study conduct and supporting documentation is accurate and factual. The course will also address how to uncover misconduct, as well as, dealing with its consequences, while identifying proactive solutions to prevent further problems. Included in the course work are practical examples and a roadmap for evaluating study conduct, source documents, case report forms and other study documentation through presentation and interactive case studies.

Additionally, the course will cover methods to detect misconduct and deal with fraud in clinical trials by:

  • Defining the basic requirements of Good Clinical Practices
  • Determining the appropriate duties and oversight required of the sponsor, monitor, and investigators to ensure a high level of quality in a clinical trial
  • Ensuring that quality practices are designed and implemented to guarantee compliant clinical trials
  • Learning how to effectively manage a Sponsor, as well as, an FDA GCP inspection
  • Developing mechanisms to uncover and preclude fraud and misconduct in clinical trials
  • Building trial guidelines/structure which will easily identify any misconduct and which is capable of quickly addressing any issues that arise in order to avoid regulatory consequences

1. This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.

2. This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.

Learn more about the course and register.

CfPIE is a preferred provider and offers MichBio members a 15% discount on course registration fees. Click here for more information.

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