This two-day course is designed for individuals who are responsible for Good Clinical Practice (GCP) compliance, including those who plan, oversee, conduct, monitor and audit clinical investigations and clinical services vendors.  This includes, but is not limited to, sponsor personnel such as clinical scientists, clinical research associates, quality assurance personnel, safety reporting staff and document control managers.  The course will also benefit research compliance personnel from clinical trial sites.



Learning Objectives

Upon completion of this course, attendees will have a better understanding of pharmaceutical, biological and medical device GCP regulations and standards related to the conduct of clinical investigations, and will have gained the background knowledge necessary to effectively plan, conduct and oversee audits under these standards.  Participants will review the steps involved in preparing for and carrying out GCP audits, including writing the audit report and developing corrective action plans.  Attendees will acquire insight into the common pitfalls identified during these GCP audits and how to avoid them.

Course Description

GCP regulations and standards apply to clinical trials of investigational pharmaceuticals, biologics and medical devices.  Failure to conform to these requirements may result in inadequate human subject protection and doubts about data quality and integrity. This course provides a comprehensive overview of how to carry out GCP audits.  Course content will prepare attendees for carrying out and following through on internal and external GCP audits.

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