FDA Inspections of Clinical Data Systems
Dublin, Ireland, 26.04.2010 - 27.04.2010

This course explores the preparation for FDA systems inspections focusing on establishing a new program or seeking improvements in an ongoing quality initiative. The course provides practical information for improving presentation and substance of Clinical Data Systems documentation in anticipation of a FDA Inspection. In addition, the course will address critical issues and potential observations resulting from a Clinical Data Systems audit. Topics include the following: inspection fundamentals; computer validation and Part 11 inspection concerns; assessing standard operating procedures; assessing system documentation; preparing for the inspection; and maintaining compliance.

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