GCP: Preparing for an Audit or Inspection
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Download Tuesday, May 26, 2026 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
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Free Trial CoursesOutline:Introduction: This session explains the reasons for having audits/inspections, introduces the people involved in them and clarifies the general terminology and main differences between the US and European systems. The Investigator's audit/inspection: This session outlines which functions, processes and documentation are audited/inspected at the investigator's site and what personnel at the site need to be aware of in order to prepare. The sponsor's audit/inspection: This session outlines which functions, processes and documentation are audited/inspected at the sponsor's site and what personnel at the site need to be aware of in order to prepare. Audit/inspection of external suppliers: This session focuses on the arrangements that need to be in place between sponsors and external suppliers to ensure that causes for concern affecting audits/ inspections are properly managed. Tools and case studies: Case studies help to review newly acquired knowledge and set it in a realistic context. An audit/ inspection checklist is also provided as reference material. | Objectives:Students completing this course should be able to: Understand the reasons for audits and inspections. Explain what needs to be done prior to an audit/inspection of a sponsor's site. Explain what needs to be done prior to an audit/inspection of an investigator's site. Understand the audit/inspection of external supplier | |
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