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Reload This Page ISO 13485 Similarities to 21 CFR Part 210/211 (Pharmaceuticals) for Quality systems
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Old 15th February 2007, 01:12 PM
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jfount jfount is offline
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Please Help! ISO 13485 Similarities to 21 CFR Part 210/211 (Pharmaceuticals) for Quality systems
Can any one describe the differences or similarities between
ISO XXXX and 21 CFR part 210/211 (Pharmaceuticals) for Quality systems

I have seen multiple comparison charts within the forum describing the differences between ISO 9000:2000 and ISO 13485:2003 is there anyone who might have something similar for ISO XXXX and CFR part 211.


thank you
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Old 6th March 2007, 05:19 PM
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Default Re: ISO 13485 Similarities to 21 CFR Part 210/211 (Pharmaceuticals) for Quality syste
Here is an attachment from:"Eastern Research Group, Inc. 110 Hartwell Avenue Lexington, MA 02421":gmp-COMPARISON.pdf
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Old 13th March 2007, 06:56 PM
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Default Re: ISO 13485 Similarities to 21 CFR Part 210/211 (Pharmaceuticals) for Quality syste
Thank you for that
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Old 13th March 2007, 07:22 PM
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Default Re: ISO 13485 Similarities to 21 CFR Part 210/211 (Pharmaceuticals) for Quality syste
You are very welcome!
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