Two FDA References

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I came across a couple of GMP/QSR references that would be good for most device firms to keep on hand.

The first one is the updated edition of The FDA and Worldwide Quality System Requirements for Medical Devices.  Kim Trautman is no longer the editor, but it should not matter. In case you are not familiar with the book, it is one of those great ideas I should have done years ago but never got around to. It goes through each section of the standard (like auditing or corrective action, for example) and lists the verbatim text of the US regulations, the ISO standard, and all of the pertinent guidance documents. It does not really matter who authored the book since most of the text was written by the FDA. It is only available via Quality Press at http://www.asq.org/, and I have a link to it at my web site under Downloads.

The second item is something published by the FDA for Consumers. It is called FDA 101: How to Use the Customer Complaint System and Medwatch.  The interesting thing about this is page 3 with the table Problems to Report to Medwatch. It talks about how the agency parses customer complaint information, and I thought it was a brilliant way to do this internally. Instead of spending countless hours figuring out how to classify complaints, and determine if they require investigation, this method would unequivocally show that not only are complaints taken seriously by the firm, but the classifications could be used to direct root cause investigations and make them more generic for regulatory review.

If you would rather talk about this in person, give me a toll-free call at 888-900-9813.