Auditing and Inspecting Clinical Research in the Global Environment
This course is not currently scheduled. Click on the Notify Me button to the left to be notified when it is scheduled.
This course is available as a client site course. Please click here for more information.
Who Should Attend
This course is designed to prove invaluable for all Clinical Research professionals regardless of experience or training. Learning opportunities are provided for front-line personnel in Clinical Research, from Clinical Research Associates through Quality Assurance Directors.
Description
This course will cover the scope of planning and conducting Good Clinical Practice Audits in an international regulatory environment. The course will present information on developing an international audit plan, areas for in-depth audits and reviews (e.g. investigator audits, system audits, computer validation audits, clinical project and system audits). Qualifications and training for staff, regulatory and ethical responsibilities for quality assurance, preparing for regulatory inspections, legal aspects in clinical research, and comparisons of international regulations will also be covered.