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                Field Management Directives

Field Management Directives

                        


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          Field Management Directives
          Criteria RequiredField Management Directives Criteria Required
  
  	
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    Print**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

                                                                                  Content current as of:
      05/08/2015Field Management Directives

          
                        


                        Canceled FMDs
 
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