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FDA Resources

FDA's Guide to Inspections of Quality Systems (QSIT) (Handbook and CD-ROM Training Program)

QSITA tool for medical device manufacturers to use in preparing for the FDA's inspection process, Quality System Inspection Technique (QSIT). The 100+ page handbook provides guidance to FDA field staff who manage the QSIT process. Includes flow charts and checklists of information that will be verified during the QSIT process. The CD-ROM contains the same training program used by FDA to train their inspectors in QSIT. 1999.

FDA Training Videotapes

This popular set includes three FDA training videos on the 1996 GMP/Quality System Regulation. Produced June 1996, 4 hours.


Order Information:
Order Code
Member Price
List
Price
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Online
QSIT Handbook
QSIT
$30
$40
Buy Online
QSIT CD-ROM
QSIT-CD
$30
$40
Buy Online
QSIT CD-PDF
QSIT-PDF
$30
$40
Buy Online
FDA Training Videotapes
GMPFDA
$80
$115
Buy Online

Or order by phone at 1-877-249-8226 or 240-646-7031.

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