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  Post Number #1  
Old 3rd November 2009, 10:02 PM
QE's Avatar
QE

 
 
Total Posts: 248
Question FDA Inspector - What does it take to become an FDA inspector?

Dear Coves

I am a quality engineer and will like to know what does it take to become an FDA inspector ? can some one describe the path to becoming an Expert ?

- QE.

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  Post Number #2  
Old 4th November 2009, 04:04 PM
gar4guv

 
 
Total Posts: 60
Re: FDA Inspector - What does it take to become an FDA inspector?

getting the job initially is the same as any other federal job: have a college degree, some experience in the medical manufacturing field, and doing well on the interviews.

passing the certification process is a little tougher. you observe a couple audits, then perform some joint audits, then you perform an audit by yourself with an inspector evaluating your work. its not a formality, some people make it, some have to go back to doing simpler audits such as foods or drugs.

to become an expert means you have to be an expert in the law. in particular the Food, Drug, and Cosmetic act. i don't think being a CQA, CQE, or SSBB will help that much. medical device experts have a lot of experience in the agency (20+ yrs) and are usually called on for assisting in possible criminal investigations or to explain the FDA's position in court.
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  Post Number #3  
Old 4th November 2009, 04:28 PM
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QE

 
 
Total Posts: 248
Please Help! Re: FDA Inspector - What does it take to become an FDA inspector?

Is this process described on the FDA's website ?




Quote:
In Reply to Parent Post by gar4guv View Post

getting the job initially is the same as any other federal job: have a college degree, some experience in the medical manufacturing field, and doing well on the interviews.

passing the certification process is a little tougher. you observe a couple audits, then perform some joint audits, then you perform an audit by yourself with an inspector evaluating your work. its not a formality, some people make it, some have to go back to doing simpler audits such as foods or drugs.

to become an expert means you have to be an expert in the law. in particular the Food, Drug, and Cosmetic act. i don't think being a CQA, CQE, or SSBB will help that much. medical device experts have a lot of experience in the agency (20+ yrs) and are usually called on for assisting in possible criminal investigations or to explain the FDA's position in court.
  Post Number #4  
Old 4th November 2009, 04:55 PM
gar4guv

 
 
Total Posts: 60
Re: FDA Inspector - What does it take to become an FDA inspector?

I don't think so. They only list the qualifications for a Consumer Safety Officer (FDA speak for an investigator)

http://www.fda.gov/AboutFDA/Workinga.../ucm113286.htm
  Post Number #5  
Old 4th November 2009, 05:03 PM
MIREGMGR

 
 
Total Posts: 3,685
Re: FDA Inspector - What does it take to become an FDA inspector?

Hiring Initiative:Job Fair schedule
Professional Meeting and Conference schedule

At the Working at FDA page, other divisions are listed as hiring, but not CDRH. However, perhaps that's a matter of terminology, with CDRH's positions categorized otherwise.
Thanks to MIREGMGR for your informative Post and/or Attachment!
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