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

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 |
|
$30 |
$40 |
|
| QSIT CD-ROM |
|
$30 |
$40 |
|
| QSIT CD-PDF |
|
$30 |
$40 |
|
| FDA Training Videotapes |
|
$80 |
$115 |
|
Or order by phone at 1-877-249-8226 or 240-646-7031.
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