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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: Sorry Currently Out of
Stock: $247.00
Available for Immediate
Download
(PDF):
$99.00
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)!
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