ORQA Auditing

Request an Audit

Please complete the ORQA Audit Request Form. An ORQA member will contact you shortly.

FDA Inspection Resources

• ORQA FDA Inspection Preparation Guide
  • APPENDIX A: FDA Inspection Initial Contact Form
  • APPENDIX B: Administrative Checklist
  • APPENDIX C: Regulatory Documents Review Tool
  • APPENDIX D: Subject Chart Review Tool
  • APPENDIX E: Daily Report Form
  • FDA Inspection Request Tracker
  • FDA Inspector PI Questions

External Audit Resources

• External Audit Request Tracker
• More resources coming soon!

Corrective Action/Preventive Action (CAPA) Resources

• 5 Whys Worksheet
• CAPA Explained
• Georgetown CAPA Template
  • if you need assistance in developing a CAPA plan, email ORQA at ORQA@georgetown.edu
• Georgetown CAP Template