Preparing for initial FDA inspection - What must I do?

J

jonathan

#1
In the middle of March, FDA inspector will come to my company to perforom the initial inspection. What must I do? :(
 
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J

jonathan

#3
Hi Al Rosen,

I had read your post. It is very good, and I have cited it as the reference for our preparation. And I have viewed Factory inspection and QSIT, but they are too general. Where can I get the detailed guidance. Thanks very much.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#5
jonathan said:
In the middle of March, FDA inspector will come to my company to perforom the initial inspection. What must I do? :(
I am not endorsing this, but I received this annoucement and thought of passing it along. If your organizations is willing to pay for it, it might be useful, but once again, I am not endorsing it. ***DEAD LINK REMOVED***
 
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M

maryloup

#6
Dear All,
I would like to know how we can manage the things when the procedures in place are not written in English/American and that people don't speak very well English. Should the master procedures be in English ? Should the company hire a translator ? Many thanks, BR.
 

Ajit Basrur

Staff member
Admin
#7
Dear All,
I would like to know how we can manage the things when the procedures in place are not written in English/American and that people don't speak very well English. Should the master procedures be in English ? Should the company hire a translator ? Many thanks, BR.
Hello maryloup,

Firstly, welcome to the Cove :bigwave:

Typically, in most countries where English is not the spoken language, the Level 1 and 2 documents (ie. the Manual and Procedures) are bilingual - English + your native language. The Level 3 and 4 could be in your local language.

It is always good to have couple of couple who can speak both English and your language during the inspection.
 
M

maaquilino

#8
Dear All,
I would like to know how we can manage the things when the procedures in place are not written in English/American and that people don't speak very well English. Should the master procedures be in English ? Should the company hire a translator ? Many thanks, BR.
When I did internal audits of our facilities overseas, many of the procedures the employees used were in the language of the country we were in, though the policies and high-level procedures were in English. As most of the employees didn't speak a lot of English, if any, the procedures they used had to be in their native language.

We used a translator, sometimes it was an employee but it depended on whether or not we could find someone who spoke good English who also didn't have something riding on the outcome of the audit; most of the people who spoke the best English were the managers whose facilities were being audited ;) Sometimes we used an outside translator. There were a few times we got the relevant documents well ahead of time and had them translated by an outside company. Each situation is different, so you may have different resolutions. I do know when I left the company they had been looking at some translation companies to use in the future and they were also looking at some translation software that might help when doing audits.
 
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