Quality Assurance and Regulatory Compliance Office and USAMRIID FDA Risk Management. Carolyn Mentzer Chief, QARCO

Transcription

1 Quality Assurance and Regulatory Compliance Office and USAMRIID FDA Risk Management Carolyn Mentzer Chief, QARCO

2 Who We Are and What We Do USAMRIID s mission is to conduct basic and applied research on biological threats resulting in medical solutions to protect the warfighter. All medical products administered to warfighters require FDA licensure. FDA ensures that medical products are safe and effective.

3 FDA Quality Management Systems FDA requires safety and efficacy studies conducted in animals and in human clinical trials. GLP - Preclinical safety and animal efficacy studies must comply with 21 CFR 58 Good Laboratory Practice. GCP - Clinical Trials in Humans must adhere to FDA s Good Clinical Practices. GLP/GCP compliant studies are essential to FDA product licensure.

4 GLP and GCP Requirements Quality Assurance (QARCO) oversight Facilities and equipment are demonstrated to be adequate for intended use Controlled SOPs signed by management and followed by study personnel Approved protocols, final reports and documentation adequate to completely reconstruct the study GLP or GCP compliance = reliable data with integrity

5 USAMRIID s Compliance Infrastructure Prevents Mission failure Unsafe or ineffective medical products being administered to soldiers Loss of reputation and funding FDA official actions GLP and GCP compliance mitigates risk.

6 QARCO Mitigates USAMRIID s Regulatory and Public Opinion Risk Auditing clinical and animal studies at all stages of conduct and completion Maintaining USAMRIID s compliance infrastructure including the controlled SOP system Hosting FDA and collaborator capability inspections Managing USAMRIID s computer and equipment validation program QARCO is USAMRIID s risk mitigation department

7 QARCO Quality Assurance An independent and objective tool for management Reports audit findings to USAMRIID Deputy Commander and POCs to assure compliance Tracks issues for management through the corrective action and preventative action, CAPA, system and through periodic status reports Provides training, SOP review and validation activities institute-wide QARCO keeps USAMRIID Command informed and in control.

8 QARCO Staff Regulated, industry-trained and experienced GLP scientific auditors, most with Master s degrees 4/5 are BPRP-enrolled with access to biosafety level BSL-3 and soon BSL-4 suites GCP auditors are registered nurses QARCO staff is highly qualified.

9 QARCO s Document Control Office Manages Regulatory Risk Controlled document management system for 1719 SOP documents that meets regulatory requirements Also complies with DA PAM and requirements Institute-wide accessibility of version-controlled documents via RIID-Vision Controlled SOP administration, periodic review, and training schedule QARCO maintains USAMRIID S SOP system.

10 Glossary 1. BPRP Biological Personnel Reliability Protection program, an Army-mandated program that ensures those personnel with access to Biological Select Agents and Toxins are fit and reliable. 2. BSL Biosafety Level Laboratories that employ engineering and PPE controls to enable laboratorians to work safely with pathogens. BSL-3 and BSL-4 are considered high levels of containment. 3. CAPA Corrective Action and Preventative Action a system that tracks corrective action from discovery to completion. 4. DA Department of Army. 5. DA PAM Department of Army Pamphlet a written guidance provided by the Army to facilitate adherence to DA Regulations. 6. FDA US Food and Drug Administration. 7. FPI Facility / Process Inspections 8. GCP Good Clinical Practice is a robust quality management system required by FDA in greater than minimal risk clinical trials. 9. GLP Good Laboratory Practice, 21 CFR 58, is a robust quality management system required by FDA in nonclinical safety and efficacy studies. 10. ISO International Standards Organization a quality system employed by USAMRIID s Unified Culture Collection laboratory in Diagnostics Systems Division. 11. LATG Laboratory Animal Technologist, a credential bestowed upon highly qualified candidates by the American Association of Laboratory Animal Science. 12. QA Quality Assurance 13. QARCO Quality Assurance and Regulatory Compliance Office. 14. RIID Vision USAMRIID s Intranet. 15. RN Registered Nurse. 16. RQAP Registered Quality Assurance Professional, a credential bestowed upon highly qualified candidates by the US Society of Quality Assurance. 17. SOP Standard Operating Procedures written procedures signed by management adequate to insure the quality and integrity of the data generated in the course of a study.