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  ATTACHMENT B

Criteria Required for Nomination to the FDA International Inspection Cadre

BASIC REQUIREMENTS:

Investigators:

• Grade GS-12 (Journeyman Level) or above
• Completed 6-month OJT using FDA Investigational Training Manual
• Basic Law and Evidence Development Course
• Investigative Interviewing Course
• At least three years conducting independent inspections in preferred program area(s)
• Demonstrated ability to prepare concise, accurate, and timely ElRs and FDA 483s as required by IOM, FMDs, etc.
• Demonstrated ability to communicate orally.
• Excellent working knowledge of FDA’s laws, policies and procedures. As a representative of the FDA and the U.S. Government, the candidate must have a demonstrated professional demeanor and ability to communicate agency requirements, policies and procedures.

Analysts:

• Grade GS-12 (Journeyman Level) or above
• Documented completion of a 6-month OJT
• Basic Law and Evidence Development Course
• At least three years conducting team inspections in preferred program area(s)
• Demonstrated ability to prepare concise, accurate, and timely ElRs and FDA 483s as required by IOM, FMDs, etc. (Only in the area of review for which they have responsibility.)
• Demonstrated ability to communicate orally.
• Excellent working knowledge of FDA’s laws, policies and procedures. As a representative of the FDA and the U.S. Government, the candidate must have a demonstrated professional demeanor and ability to communicate agency requirements, policies and procedures.

SPECIFIC REQUIREMENTS FOR INVESTIGATORS:

Drug Investigators: Successfully completed Basic Drug Manufacturing Quality Control Course and Industrial Sterilization (or equivalent**).

Device Investigators: Successfully completed Basic Medical Device Training Course and Process Validation or Industrial Sterilization (or equivalent**).

Biologics Investigators: Blood Banks/Plasma Center: Completed Basic Blood Banking and Plasmapheresis Course and Advanced Blood Banking and Plasmapheresis Course (or equivalent**). Biologics Products: Drug Manufacturing and Quality Control and Industrial Sterilization (or equivalent**).

Food Investigators: Successfully completed LACF or Seafood HACCP and Basic Microbiological Training Course.

BIMO Investigators: Successfully completed Clinical and/or Non-Clinical Bioresearch Monitoring Training Course (or equivalent**).

SPECIFIC REQUIREMENTS FOR ANALYSTS:

Must document training/experience to reflect adequate knowledge/skills/abilities in the program area proposed for nomination. A proven track record showing experience on team inspections, or letters of commendation, etc., for performance on team inspections.

SPECIALIZED REQUIREMENTS FOR INVESTIGATORS AND ANALYSTS:

(Not mandatory, except for certain program areas, as described under specific requirements, if the Investigator/Analyst can show alternate experience in lieu of FDA requirement)

Courses in:

• Process Validation
• Industrial Sterilization
• Computer System Validation
• Statistical Process Control
• Orientation to International Inspections
• Epidemiology
• Pre-Approval Inspections
• Fractionation Course
• IVD Course
• Biotechnology Course
• Allergenic Products Course
• Vaccines Course

**

      Equivalent or alternate experience based on inspection experience (e.g., conducted three or more independent inspections in the program area showing competency and understanding of concepts along with additional OJT experience). Level II Device Certification is deemed equivalent.

This page was last updated on: 02/12/2003.

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