Electronics Forum | Wed Feb 22 09:10:40 EST 2006 | samir
Is this a FDA type validation?
Electronics Forum | Wed Feb 22 10:45:05 EST 2006 | Gilligan
FDA = Food and Drug Administration. Typically, the FDA requires a validation of every product that will ultimately go to consumers. The validation process is the basic "run it the same way with the same results" over a period of time. Back in my Phar
Electronics Forum | Thu Feb 23 02:46:16 EST 2006 | INGE
It isn't an FDA validation. I think Steve has centered the problem. I have already defined all the steps and all the procedures of the process, but now I must run X boards, Y times, through each piece of equipment (as he said before); the question is
Electronics Forum | Wed Feb 22 12:19:49 EST 2006 | Dirka Jihabi
I worked for a EMS who makes Medical Device Electronics, and yeah, the FDA's methodology for validation is a complete cluster-fudge! They did it on the principle of...does the shop air going into your equipment REALLY 80 PSI...or is there REALLY 220
Electronics Forum | Wed Feb 22 20:38:04 EST 2006 | davef
Dirka Jihabi The FDA doesn't care about the method your company chooses. FDA require in their "Good Manufacturing Practices [GMP]" that your company defines a method and abides by that method. Now, if the fine folk at your company selected a naive
Electronics Forum | Wed Feb 22 09:51:49 EST 2006 | INGE
Sorry, but FDA is the acronym of what? Thanks
Electronics Forum | Wed Feb 22 20:11:59 EST 2006 | slthomas
*Qualify* your equipment by running X boards, Y times, through each piece of equipment under normal operating conditions and quantifying the performance, as in a ppm rating. Then validate your process by defining all of the steps you use to generate
Electronics Forum | Tue Feb 25 13:44:12 EST 2003 | slthomas
One addition to Dave's comments.....my previous experience yielded one key observation about the differences between ISO audits and GMP (FDA) audits: ISO audits were to establish that you had a documented process, complete with procedures, establishe
Electronics Forum | Mon Feb 24 20:37:01 EST 2003 | davef
Key Food and Drug Administration [FDA] Compliance Guidelines are in: * Blood/Biotechnology * Cosmetics * Drugs * Food * Medical Devices * Positron Emission Tomography The medical device industry adheres to the rules of Good Manufacturing Practice (G
Electronics Forum | Mon Apr 21 13:48:32 EDT 2003 | davef
ISO 9001-1994 and ISO 9001-2000 are significantly different regarding 'process'. In the 1994 version, processes were considered to be routine manufacturing processes [eg, drill a hole]. In the new ISO, a 'process' is more global and covers anything
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