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  1. Inspection References

Criteria Required

Criteria Required

Subject:
Criteria Required for Nomination to the FDA International Inspection Cadre
Area:
Operations Management
Date Revised:
March, 16 2009
 

ATTACHMENT B

Guiding principles for determining qualified international inspection personnel

BASIC REQUIREMENTS:

Investigators:

  • Grade GS-12 (Journeyman Level) or above (or commissioned corps equivalent)

    Note: If field management is confident that the GS-11 (or commissioned corps equivalent) employee meets the experience and skill requirements they may be considered qualified to conduct international inspections.

  • Completed 6-month OJT using FDA Investigational Training Manual
  • Basic Law and Evidence Development Course
  • Investigative Interviewing Course
  • Experience conducting independent inspections in the domestic arena for the foreign inspection program area being considered.
  • 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 (or commissioned corps equivalent)

    Note: If field management is confident that the GS-11 (or commissioned corps equivalent) employee meets the experience and skill requirements they may be considered qualified to conduct international inspections.

    • Documented completion of a 6-month OJT
    • Basic Law and Evidence Development Course
    • Experience conducting team inspections in the 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.

SUGGESTED REQUIREMENTS FOR INVESTIGATORS:

  • Drug Investigators: Successfully completed Basic Drug Manufacturing Quality Control Course, Inspection of Active Pharmaceutical Ingredient Manufacturers and Industrial Sterilization (or equivalent**).
  • MedicalDevice 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:

Employees must document training/experience to reflect adequate knowledge, skills and 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