jfount
9th January 2007, 10:11 AM
I have worked exclusivley in ISO 9000 mfg facilities, and ISO 13485, I have recently transferred over to a Pharma company and am currently involved in compliance. I have been an avid reader of elsmarCove actually for more years than my latest profile suggests.
My question is, does anyone know of a similiar forum for Pharmaceuticals?
I have received so much help and knowlege from this forum. (for which I am eternally grateful) I am looking for the same in the CFRs
Randy
9th January 2007, 11:11 AM
Nobody understands the CFR's, they're written by government agency, civil service personnel and lawyers, based upon legislation passed by the US Congress (also a bunch of lawyers).
jfount
9th January 2007, 12:36 PM
So I shouldn't expect another forum to be available?
Doug Tropf
9th January 2007, 01:18 PM
I have "stumbled" across forums relating to pharmaceuticals in the past, but being in the medical device end of the industry, I didn't keep any info about them. Have you tried searching the internet?
jfount
9th January 2007, 03:05 PM
Nothing like this...The best pages I can find are in the FDA websight, there is a great deal of information, but not like the help provided in these forums
I'll just keep hoping soemone maybe has the foresight to start such a web sight. And I'll continue to look. thanks
Randy
10th January 2007, 12:25 AM
Hey, start your own Thread and get something flowing right here. There is no better place on the planet.
jfount
10th January 2007, 08:00 AM
I don't think I would know how.
And besides, this forum seems to deal strictly with ISO.
I wouldn't want to bog down anything,
Thanks for the help
Al Rosen
11th January 2007, 10:37 AM
I don't think I would know how.
And besides, this forum seems to deal strictly with ISO.
I wouldn't want to bog down anything,
Thanks for the helpYou won't bog down anything. This forum is for Food and Drug related issues not just ISO.
This thread has been moved to the ISO 22000 and FDA (Food and Drug Safety) (http://elsmar.com/Forums/forumdisplay.php?f=90) forum.
BradM
11th January 2007, 11:00 AM
Randy is correct. Interpreting the CFR and the USP is a mammoth undertaking.
In my opinion:
Many of the important, relevant factors become requirements within the QMS of the organization.
If you are a member of ASQ, they also have a FDA forum.
Too, finding the forum for relevant portions of the code may be contingent on the area. For example, you may have to locate forums in Analytical Chemistry for those areas, toxicology for those, etc.
