1. FDA’s Pharmaceutical Inspectorate Robert Coleman National Expert Drug Investigator Food and Drug Administration

2. Certification

3. Background Certification begun in 1994 To create consistent inspectional activities nationally through a uniformly managed training & audit process for our investigators. Will proceed as long as adequate funding and support exists.

4. Purpose Provide training to develop & maintain a qualified & effective staff of investigators. Provide a structured mechanism for investigators to obtain, maintain & consistently apply the required competencies Objective: Assure our Investigators continue to have the skills & knowledge necessary to do their jobs.

5. Players Human Resource Committee Division of Human Resource Development Course Advisory Committee(s) Certification Board(s) Performance Auditors Certification Candidates District Management Office of the Director of Regional Operations Division of Field Investigations

6. Program Areas with Certification Medical Devices BloodSeafoodDrugs

7. Drug Certification Level I Level II Level III

8. Level I Mandatory For all new hire investigators Training completed in the first 12- months. Demonstration of competency via a successful performance audit results in Level I Certification.

9. Level I Training Web based training courses and OJT experience Classroom training courses –Basic Food and Drug Law –Evidence Development –Investigative Interviewing –Quality Auditing

10. Level I Audit Criteria First line supervisor looks for: –General Investigational Practices –Evidence Recognize, Collect and Identify Appropriate Evidence to Support Findings –Verbal Communication –Written Communication –Professionalism

11. Level II Drug Certification Not mandatory Candidate must –Spend at least 25% of time in drug program –Submit packet to Level II Drug Certification Board –Pass performance audit –The Performance Auditor is a Board Approved FDA employee who completed their Level II Certification –Be recertified every 3 years (18 CEU hours)

12. Level II Drug Investigator Certification Prerequisites Must meet Level I criteria Required training courses –Drug Manufacturing & Quality Control Training Course –Pre-Approval Inspections Training Course –Industrial Sterilization of Drugs & Devices Training Course –Computer Systems Validation Training Course –Active Pharmaceutical Ingredient Manufacturing Training

13. Level II Certification Board National Expert Experienced Field Investigator Expert from CDER Expert from CVM Field Manager DHRD Specialist

14. Level II Audit Criteria Compliance assessment Evidence Verbal Communication Written Communication Professionalism

15. Level III Drug Certification AKA “Pharmaceutical Inspectorate” Not mandatory Planning for 50 members by FY07

16. Who is eligible for the PI? FDA employees with at least 3 years of experience in inspecting drug firms. –ORA Field Investigators –CDER/CVM personnel –Investigative analysts Certified at Level II –Must pass a six system audit Endorsed by District/Office management Selected/nominated by Level III Certification Board

17. How do they join? Submit their name to their supervisor for consideration. Initial nomination will have concurrence from their District management. Submit a certification packet to the Level III Drug Investigator Certification Board for review and selection. The Certification Board will screen the applicant.

18. Level III Drug Certification Board 2 Field Investigators (National Experts) operating at Level III 2 Experts from the CDER 2 Experts from the CVM 1 DFI Program Expert 1 ORA Field Manager from the appropriate Field Committee 1 Representative from DHRD

19. Who are the candidates? FDA personnel (mainly Investigators) with specialized experience & specific training in evaluating pharmaceutical manufacturing. Report directly to ORA District Office management for assignments. Spend about 80% of their time conducting drug inspections (domestic & foreign) and related activities.

20. Expected Competencies for PI Regulating Pharmaceutical Quality and the Relationship to FDA’s Mission Risk Management Advanced Quality Systems Pharmaceutical Science Current Regulatory Programs and Procedures TechnologyInvestigational

21. Selection Criteria for the PI Candidate demonstrates: –Willingness to share his/her knowledge with colleagues –Initiative to go beyond the “expected” or “required” –Innate ability to separate important issues from unimportant issues –Currency of knowledge –Desire to excel

22. Selection Criteria for the PI Candidates will: –Primarily focus on conducting pharmaceutical inspections –Successfully meet all Level I and Level II requirements –Recognize when additional training is needed –Be a recognized resource on advanced technology or inspectional techniques –Demonstrate effective verbal and written communication skills

23. Admission to the PI To become a PI member the candidate must: –Have their packet successfully reviewed –Pass the screening –Pass the training –Participate in Center details –Pass final evaluation

24. What training will be provided? First course completed in 2005 Second course scheduled in 2006 –Still under development

25. Some Course Agenda Items Quality Systems & Tools Risk Assessment & Management Critical Thinking Quality by Design Design of Experiments ICH Guidances Process Capability Technology Transfer CAPAPAT

26. PI Course Advisory Group ORA, CDER training manager & trainers ORA/DFI representatives ORA Field investigator ORA Field Manager CDER, CVM representatives Others (on a course by course basis)

27. PI Expectations Seek additional activities to further their expertise. Develop & implement formal training programs for FDA, industry, and state/local officials. Develop/evaluate programs, policies, or procedures in their area of expertise. Auditors for the Level II or III Drug Certification programs. Participate in professional activities that maintain, broaden, or enhance their knowledge.

28. HOW TO REACH ME Robert C. Coleman US FDA 60 Eighth Street, N.E. Atlanta, Georgia 30309 USA Tel: 404-253-1295FAX: 404-253-1205 Email: Robert.Coleman@fda.hhs.gov Robert.Coleman@fda.hhs.gov