Attachment A of FMD 13A
Request for Nomination to the FDA International Inspection Cadre
Candidate's Name: _________________________________________________________
Grade Level and Title: ________________________________________________________
FDA Address: ______________________________________________________________
Mail Code: ________________________________________________________________
Phone/FAX Numbers: ________________________________________________________
Program Area(s) Expertise (specify the areas within the program area in which you have experience; e.g., biologics, blood banks vs. plasma centers; for devices, lVDs vs. plastics; for drugs, bulks vs. finished pharmaceuticals):
Training Courses taken to demonstrate knowledge/expertise in these program areas:
Basic Law/Evidence Development – Date:
Investigative Interviewing – Date:
Basic Drug/Device/Biologics/Food Micro./Better Processing School/BIMO (circle those that apply and give dates).
Advance Courses (course title) – Dates:
How long have you been conducting inspections? Describe the type of inspections you have conducted in your preferred Program area. (For example, sterile drug/device inspections; bulk drugs vs. finished pharmaceuticals; and capsules and aerosols vs. tablets or ointments; electronic devices vs. lVDs, etc.).
Have you ever conducted international inspections? If so, please describe the type of inspections and the dates (months/year).
Have you attended the ORA International Inspection Course. If so, when?
For Information Purposes Only:
For Investigators in program areas with Certification Programs — Are you certified? If so, at what level? In what program area(s)?
For ALL Investigators and Analysts: What other languages do you speak, read, are proficient in?
Academic Achievements beyond a BS or BA Degree (list degrees obtained; post-graduate work; or other academic courses taken to enhance your technical abilities):
Candidate’s Signature: _________________________
Date: _____________________
The following signatures and concurrences certify that the candidate meets the criteria described in FMD 13A for Investigators and Analysts conducting International Inspections.
Immediate District Management Concurrence:
Printed Name and Position: _______________________
Signature/Date: ___________________________
Comments: ________________________________________________________________
__________________________________________________________________________
District Management Concurrence:
Printed Name and Position: _______________________
Signature/Date: ___________________________
Comments: ________________________________________________________________
__________________________________________________________________________