FDA’s Pharmaceutical Inspectorate

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 • Blood • Seafood • Drugs

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 • Technology • Investigational

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

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: 404-253-1295 FAX: 404-253-1205 Email: Robert.Coleman@fda.hhs.gov