|
|
|
|
||
|
HELP | |
|
On Order $427.75
New Loose Leaf
Currently out of stock.
 available for shipping or prepaid pickup only
This title in other formats:GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, Sixth Edition, (Volumby Leonard Steinborn
Synopses & ReviewsPublisher Comments:Volume 1 of this three-part package provides a complete set of checklists for internal and contract device and drug manufacturers and developers, contract software developers, and suppliers of chemical, printed material, electronic component, and general supplies. It also includes a simulated QSIT audit, and a new-product market launch. All of these are referenced to the relevant relevant FDA regulations, EC and IPEC guidelines, and ISO/BSI standards. The text also explains various audit types, do's and don'ts for auditors, and guidance for audit preparation, performance, conclusion, report derivation, and follow up activities. A CD-ROM packaged with the book contains all of the checklists in a customizable electronic format. Book News Annotation:A veteran of quality in medical device and pharmaceutical industries,
Steinborn updates again the guide he first wrote in 1984. He details
what quality control and quality assurance measures are needed in
those industries above and beyond those required in other industries,
because of product liability and regulatory conditions. He describes
the basic tools needed to perform compliance audits, and the various
audit types. Manufacturers of finished products are his main concern,
but for suppliers to companies in the industry, he also explains what
to expect when a quality audit is anticipated. Most of the book and
all of the disk are devoted to detailed audit questionnaires and
checklists, which can be copied and used directly. There is no index.
No information is provided about subsequent volumes. Loose-leaf bound.
Annotation (c)2003 Book News, Inc., Portland, OR (booknews.com) What Our Readers Are SayingBe the first to add a comment for a chance to win!Product Details
Related Aisles
| |||||||||
|
| ||||||||||
|
||||||||||
Don't Miss
