|
|
|
|
|
| |
 |
|
 |
| |
Copyright 2006, 328 pages
ISBN 0-9780704-0-2
 |
Interpretation of FDA's Quality
System Regulations (QSR) With
QSIT references A complete
compendium to the Food and Drug
Administration's (FDA) Quality
System Regulation (QSR) with
relative references to FDA's
Quality System Inspection
Technique (QSIT). This book takes into account
the latest up-to-date trends in
Agency views.
Soft Cover:
$247
Sorry
Soft Cover - OUT OF STOCK.
|
|
|
To see free excerpts from
this book - listed in Google
Books Click Here |
|
|
You will want to keep this
book in reach when:
- Developing policies
and procedures
- Preparing for FDA
audits
- Responding to 483
Observations and Warning
Letters
Conducting Internal
Audits or determining
Gap Analysis
Each chapter restates the
requirement, then leads into
an interpretation/discussion
of the important sections.
Relevant portions also
include:
- Industry Practices
- Definition Checks
- Cautionary remarks
- QSIT Reference
(understanding exactly
what the FDA will
concentrate on during
audits - and the sorts
of questions they will
ask)
- Available for
immediate download
(electronic PDF
version)!
|
|
|
|
|
|
