Establishing Compliant and Effective Document Control Systems for FDA Regulated Industry

This course will provide guidance on the numbering, formats, content, review and approval for documentation in a FDA regulated environment. It will explain the criticality of documenting discrepancies and follow up corrective actions and change controls. It will outline all the quality systems documents that should be interlinked to maintain control and compliance with Good Manufacturing Practices. Moreover this seminar will teach how to establish user requirements for off the shelf document control software, criteria to establish when purchasing such software and guidelines on its implementation.