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Training as well as certifications for ISO 13485:2016, 21 CFR 820...
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Training as well as certifications for ISO 13485:2016, 21 CFR 820...
Training as well as certifications for ISO 13485:2016, 21 CFR 820...
Training as well as certifications for ISO 13485:2016, 21 CFR 820...
Training as well as certifications for ISO 13485:2016, 21 CFR 820...
Training as well as certifications for ISO 13485:2016, 21 CFR 820...
Training as well as certifications for ISO 13485:2016, 21 CFR 820...
Training as well as certifications for ISO 13485:2016, 21 CFR 820...
Training as well as certifications for ISO 13485:2016, 21 CFR 820...
Training as well as certifications for ISO 13485:2016, 21 CFR 820...
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21 cfr part 820 - med. device mfger. qsr requirements, iso 13485:2016, online internet training courses and universities, training sources and resources
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  Post Number #1  
Old 6th December 2017, 12:04 PM
anonymous16

 
 
Total Posts: 4
Please Help! Training as well as certifications for ISO 13485:2016, 21 CFR 820...

Hello!

Does any of you know of a reliable place or online source that will provide training as well as certifications for ISO 13485/FDA QSR? It's been a while since I worked with medical devices... for the past 10 years I've been working with Pharma and Nutraceuticals... having started a new position with medical devices I'd like to get a refresher.

Thanks in advance.

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  Post Number #2  
Old 6th December 2017, 07:53 PM
Jane's's Avatar
Jane's

 
 
Total Posts: 47
re: Training as well as certifications for ISO 13485:2016, 21 CFR 820...

Hi anon, I would check BSI for online training, here is the page: Quality Management Training Solutions from BSI

Depending on where you are, you may want to look into MDSAP training and kill two birds with one stone.
  Post Number #3  
Old 7th December 2017, 05:53 PM
Ronen E

 
 
Total Posts: 3,736
Re: Training as well as certifications for ISO 13485:2016, 21 CFR 820...

Also have a look at CDRH Learn.

Not sure what you mean by “online certifications”, but in general you should be suspicious about it.
  Post Number #4  
Old 11th December 2017, 02:47 PM
Jane's's Avatar
Jane's

 
 
Total Posts: 47
Re: Training as well as certifications for ISO 13485:2016, 21 CFR 820...

Quote:
In Reply to Parent Post by Ronen E View Post

Also have a look at CDRH Learn.

Not sure what you mean by “online certifications”, but in general you should be suspicious about it.
The way I understand the OP question, online certification is taking an assessment online which successful completion (passing score) earns you a certificate which states that you have passed the assessment.

If the above is correct, and if that was your assumption too, I am not sure why the recommendation to be generally suspicious about it (suspicious about the institution, the assessment, or the person offering an online certification as their proof of qualification)?
  Post Number #5  
Old 11th December 2017, 05:45 PM
Ronen E

 
 
Total Posts: 3,736
Re: Training as well as certifications for ISO 13485:2016, 21 CFR 820...

Quote:
In Reply to Parent Post by Jane's View Post

The way I understand the OP question, online certification is taking an assessment online which successful completion (passing score) earns you a certificate which states that you have passed the assessment.
How is the identity of the person actually completing the assessment verified?
  Post Number #6  
Old 12th December 2017, 05:28 PM
Jane's's Avatar
Jane's

 
 
Total Posts: 47
Re: Training as well as certifications for ISO 13485:2016, 21 CFR 820...

That makes sense, thanks.
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