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- catalog alternative "Medical device good manufacturing practices manual.".
- catalog contributor b10352562.
- catalog contributor b10352563.
- catalog contributor b10352564.
- catalog contributor b10352565.
- catalog contributor b10352566.
- catalog contributor b10352567.
- catalog coverage "United States".
- catalog created "1996.".
- catalog date "1996".
- catalog date "1996.".
- catalog dateCopyrighted "1996.".
- catalog description "1. The quality system regulation -- 2. Quality systems -- 3. Design controls -- 4. Process validation -- 5. Personnel -- 6. Buildings and environment -- 7. Equipment and calibration -- 8. Device master record -- 9. Document and change control -- 10. Purchasing and acceptance activities -- 11. Labeling -- 12. Product evaluation -- 13. Packaging -- 14. Storage, distribution and installation -- 15. Complaints -- 16. Servicing -- 17. Quality systems audits -- 18. Factory inspections -- Appendixes: -- Quality system regulation -- Application of the medical device GMPs to computerized devices and manufacturing processes.".
- catalog description "Includes bibliographical references.".
- catalog extent "1 v. (various pagings) ;".
- catalog isPartOf "HHS publication ; FDA 97-4179".
- catalog isPartOf "Medical devices".
- catalog issued "1996".
- catalog issued "1996.".
- catalog language "eng".
- catalog publisher "Rockville, Md. : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health,".
- catalog spatial "United States".
- catalog subject "1997 F-368".
- catalog subject "Equipment Safety standards United States Guideline.".
- catalog subject "Equipment and Supplies standards United States Guideline.".
- catalog subject "Equipment and Supplies standards".
- catalog subject "KF3827.M4 L68 1996".
- catalog subject "Medical instruments and apparatus Standards United States Handbooks, manuals, etc.".
- catalog subject "Quality Control.".
- catalog subject "W 26 M48915 1996".
- catalog tableOfContents "1. The quality system regulation -- 2. Quality systems -- 3. Design controls -- 4. Process validation -- 5. Personnel -- 6. Buildings and environment -- 7. Equipment and calibration -- 8. Device master record -- 9. Document and change control -- 10. Purchasing and acceptance activities -- 11. Labeling -- 12. Product evaluation -- 13. Packaging -- 14. Storage, distribution and installation -- 15. Complaints -- 16. Servicing -- 17. Quality systems audits -- 18. Factory inspections -- Appendixes: -- Quality system regulation -- Application of the medical device GMPs to computerized devices and manufacturing processes.".
- catalog title "Medical device quality systems manual : a small entity compliance guide / Andrew Lowery, Judy Strojny, and Joseph Puleo.".
- catalog type "Guideline.".
- catalog type "Handbooks, manuals, etc. fast".
- catalog type "text".