Validating medical packaging
The FDA establishes the manufacturer's responsibility for medical device packaging, but provides no direction on how to achieve compliance. Highlighting the development in industry regulations, this book demystifies the validation procedure. It presents real-life examples and case studies, temp...
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| Main Author: | |
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| Format: | Book |
| Language: | English |
| Published: |
Boca Raton
CRC Press
2003
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| Subjects: | |
| Online Access: | Click Here to View Status and Holdings. |
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Add Tag | Summary: | The FDA establishes the manufacturer's responsibility for medical device packaging, but provides no direction on how to achieve compliance. Highlighting the development in industry regulations, this book demystifies the validation procedure. It presents real-life examples and case studies, templates for creating and maintaining a validation file. |
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| Physical Description: | 151 pages illustrations 23 cm |
| Bibliography: | Includes bibliographical references and index |
| ISBN: | 1566768071 9781566768078 |
Validation standard operating procedures a step-by-step guide for achieving compliance in the pharmaceutical, medical device, and biotech industries 
Medical device reliability and associated areas