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Validating medical packaging

Author: Ronald Pilchik
Publisher: Boca Raton : CRC Press, ©2003.
Edition/Format:   eBook : Document : EnglishView all editions and formats
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  Read more...

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Genre/Form: Electronic books
standarder
Additional Physical Format: Print version:
Pilchik, Ronald.
Validating medical packaging.
Boca Raton : CRC Press, ©2003
(DLC) 2002073339
(OCoLC)49903090
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Ronald Pilchik
ISBN: 1566768071 9781566768078 9781420014945 1420014943
OCLC Number: 309877868
Description: 1 online resource (151 pages) : illustrations
Contents: INTRODUCTION What is Validation? PACKAGE DESIGN VALIDATION Elements of Package Design Package Design Issues Validation Flow Chart Simulation Criteria Qualified Suppliers Tables 1-6 PACKAGE PROCESS VALIDATION Introduction Process Validation: What is It? IQ, OQ, PQ Process Capability Studies Example: XYZ Medical Device Corporation: Validation Protocol-Process Capability Study PUTTING IT ALL TOGETHER: THE VALIDATION PROTOCOL The Validation File File Maintenance Employing the Process Example: Package Validation File REGULATORY ACTIVITIES Selected Case Studies Packaging Non-Compliances Industry Generated Support Documents HACCP-Furthering the Need for Package Validation Appendix 1 Operations Manual (impulse Sealer)
Responsibility: Ronald Pilchik.
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