Regulatory Responsibilities of the Bureau of Medical Devices. Module IV: FDA Field Compliance Activities. Leader Guide and Student Workbook

摘要

This leader guide contains the following five components: (1) Leader Introduction, (2) Session Plan, (3) Student Workbook, (4) Pretest and Post-Test, and (5) Videotape Script. The Leader Introduction covers general planning and teaching techniques for a small or large group setting. The Session Plan provides the instructor with specific information on planning and leading a training session covering the information contained in Module IV's Student Workbook. The Student Workbook includes the organizational structure of the Office of the Executive Director of Regional Operations (EDRO) which has direct line authority over all FDA field operations. Activities such as inspections and sample collections provide the basis for a discussion on enforcement tools such as recalls, seizures, and prosecutions.