Release Date: 27 June, 2003
Ring-bound
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From Book News, Inc.
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.Copyright © 2004 Book News, Inc., Portland, OR
Book Description
Volume 1 of this two-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 Info
Offers complete checklists for internal and contract device and drug manufacturers. Includes a simulated QSIT audit and a new-product market launch, all referenced to the relevant FDA regulations and EC and IPEC guidelines. Previous edition not cited and titled GMP/ISO/EN Quality Audit Manual for Healthcare Manufacturers and Their Suppliers. Three-ring binder. Rating
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