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FDA Resources

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

    A 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. Produced in 1999.
    Order information.
  • 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 Information:
Order Code
Member Price
List
Price
Buy
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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