Hi to all,

first post in this forum for a help request.
Our plant in Switzerland was supposed to be inspected by the FDA this week, but for reasons that are still unclear this won't be the case for some time. :agree1: We've already done a lot of job to get prepared for the inspection. Now I'm going to take advantage of this delay to search for a tool that in my opinion could be fundamental in a german speaking environment: what I would like to have is a copy of 21 CFR 820 translated in German language so that everybody here in the plant can understand exactly what FDA is expecting from us. Understanding english is in fact more than an issue here :( and I'd like to spend my time doing my job rather than working as a free translation service.
Thanks in advance to any link, attachment, advice etc.

Ciao Buran73 Benveuto a la Cove provare questo indirizzio http://www.archives.gov/federal-register/cfr/
and this one www.product-lifecycle-management.com/21cfr820.htm

Hello and welcome to the Cove! :bigwave:

I looked on the FDA's website for translation information, but didn't find anything. It probably wouldn't hurt to send an email to the FDA at the address on their web site, www(dot)fda(dot)gov, and inquire as to whether they offer 21 CFR 820 in other languages (specifically, German). There is a link on there for Spanish, but it's the only one I saw.

Perhaps one of the other Covers here might be able to offer more information that will help you get what you need.

Again, welcome to the Cove! :bigwave: Feel free to post and share your experiences whenever you like. :)

Hi to all,

first post in this forum for a help request.
Our plant in Switzerland was supposed to be inspected by the FDA this week, but for reasons that are still unclear this won't be the case for some time. :agree1: We've already done a lot of job to get prepared for the inspection. Now I'm going to take advantage of this delay to search for a tool that in my opinion could be fundamental in a german speaking environment: what I would like to have is a copy of 21 CFR 820 translated in German language so that everybody here in the plant can understand exactly what FDA is expecting from us. Understanding english is in fact more than an issue here :( and I'd like to spend my time doing my job rather than working as a free translation service.
Thanks in advance to any link, attachment, advice etc.

Welcome to the Cove :bigwave:

You have asked a very valid question :applause: and I am facing the same problem here in China. For the training purpose on 21 CFR Part 820, I could not get a Chinese version; instead got hold of a guy who was good in both English and Chinese.

Through this guy, I prepared slides and text material for easy interpretation. Another thing, 21 CFR Part 820 is similar to ISO 13485, so you can strike a similarity :)

Best Luck.

Thanks to all for welcoming and particularly to Dean for the links. I agree with Qualityalways about the issue of training people on a foreign specification. I've sent out a couple of e-mails, just see if and what they answer . . .

Great links indeed...