Mastering and Managing the FDA Maze : (Record no. 33556)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 05195nam a22004333i 4500 |
| 001 - CONTROL NUMBER | |
| control field | EBC7158793 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | MiAaPQ |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20240724115726.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS | |
| fixed length control field | m o d | |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr cnu|||||||| |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 240724s2014 xx o ||||0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781636940465 |
| Qualifying information | (electronic bk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Canceled/invalid ISBN | 9780873898874 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (MiAaPQ)EBC7158793 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (Au-PeEL)EBL7158793 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC)1356006731 |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | MiAaPQ |
| Language of cataloging | eng |
| Description conventions | rda |
| -- | pn |
| Transcribing agency | MiAaPQ |
| Modifying agency | MiAaPQ |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | KF3827.M4 H376 2014 |
| 082 0# - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 344.73042 |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Harnack, Gordon. |
| 245 10 - TITLE STATEMENT | |
| Title | Mastering and Managing the FDA Maze : |
| Remainder of title | Medical Device Overview. |
| 250 ## - EDITION STATEMENT | |
| Edition statement | 2nd ed. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Place of production, publication, distribution, manufacture | La Vergne : |
| Name of producer, publisher, distributor, manufacturer | ASQ Quality Press, |
| Date of production, publication, distribution, manufacture, or copyright notice | 2014. |
| 264 #4 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Date of production, publication, distribution, manufacture, or copyright notice | ©2014. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 1 online resource (501 pages) |
| 336 ## - CONTENT TYPE | |
| Content type term | text |
| Content type code | txt |
| Source | rdacontent |
| 337 ## - MEDIA TYPE | |
| Media type term | computer |
| Media type code | c |
| Source | rdamedia |
| 338 ## - CARRIER TYPE | |
| Carrier type term | online resource |
| Carrier type code | cr |
| Source | rdacarrier |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | Cover -- Title page -- CIP data -- Contents -- Figures and Tables -- Acknowledgments -- What is New? -- Introduction -- Chapter 1_FDA Laws, Regulations, and Medical Device Oversight -- Scope -- FDA Laws -- FDA Regulations -- FDA Medical Device Oversight -- Chapter 2_FDA Inspections -- Scope -- FDA Inspections -- Chapter 3_Quality System Requirements, Management Responsibilities, and Personnel -- Scope -- Quality System -- Subpart B-Quality System Requirements -- FDA Inspection of Quality System Requirements -- Chapter 4_Design Controls -- Scope -- Design Controls -- FDA Inspections of Design Controls -- Chapter 5_Document Controls -- Scope -- Document Controls -- FDA Inspection of Document Controls -- Chapter 6_Purchasing Controls -- Scope -- Purchasing Controls -- FDA Inspection of Purchasing Controls -- Chapter 7_Identification and Traceability -- Scope -- Identification and Traceability -- FDA Inspection of Identification and Traceability -- Chapter 8_Production and Process Controls -- Scope -- Production and Process Controls -- FDA Inspection of Production and Process Controls -- Chapter 9_Acceptance Activities -- Scope -- Acceptance Activities -- FDA Inspection of Acceptance Activities -- Chapter 10_Nonconforming Product -- Scope -- Nonconforming Product -- FDA Inspection of Nonconforming Product -- Chapter 11_Corrective and Preventive Action -- Scope -- Corrective and Preventive Action -- FDA Inspection of Corrective and Preventive Action -- Chapter 12_Statistical Techniques -- Scope -- Statistical Techniques -- FDA Inspection of Statistical Techniques -- Chapter 13_Device Master Record (DMR) -- Scope -- Device Master Record (DMR) -- FDA Inspection of the Device Master Record -- Chapter 14_Labeling and Packaging -- Scope -- Labeling -- Device Labeling -- Subpart K-Labeling and Packaging Control -- FDA Inspection of Labeling -- Packaging. |
| 505 8# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | FDA Inspection of Packaging -- Chapter 15_Handling, Storage, and Distribution -- Scope -- Handling -- FDA Inspection of Handling -- Storage -- FDA Inspection of Storage -- Distribution -- Subpart L-Distribution -- FDA Inspection of Distribution -- Chapter 16_Installation and Servicing -- Scope -- Installation -- FDA Inspection of Installation -- Servicing -- FDA Inspection of Servicing -- Chapter 17_Records-General Requirements, Device History Record (DHR), and Quality System Record (QSR) -- Scope -- Records -- Subpart M-General Requirements -- FDA Inspection of Records-General Requirements -- Subpart M-Device History Record (DHR) -- FDA Inspection of Device History Record -- Quality System Record -- FDA Inspection of the Quality System Record -- Chapter 18_Complaint Files -- Scope -- Complaint Files -- FDA Inspection of Complaint Files -- Chapter 19_Unique Device Identification (UDI) System Including Applicable Parts of 21 CFR 830 and 21 CFR 801 -- Scope -- Unique Device Identification -- FDA Inspection of Unique Device Identification -- FDA Inspection of Labeling -- FDA Accredited UDI Organizations -- Chapter 20_Medical Device Reporting -- Scope -- Medical Device Reporting -- Chapter 21_Medical Devices-Reports of Corrections and Removals -- Scope -- Reports of Corrections and Removals -- FDA Inspection of Corrections and Removals -- Chapter 22_Quality Audit -- Scope -- Quality Audit -- FDA Inspection of Auditing -- Appendices -- Appendix A -- Appendix B -- Appendix C -- Appendix D -- Appendix E -- Appendix F -- References and List of FDA Offices -- Acronym List -- Glossary -- Index. |
| 588 ## - SOURCE OF DESCRIPTION NOTE | |
| Source of description note | Description based on publisher supplied metadata and other sources. |
| 590 ## - LOCAL NOTE (RLIN) | |
| Local note | Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2024. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | United States.-Food and Drug Administration Safety and Innovation Act. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Medical instruments and apparatus-Safety regulations-United States. |
| 655 #4 - INDEX TERM--GENRE/FORM | |
| Genre/form data or focus term | Electronic books. |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Print version: |
| Main entry heading | Harnack, Gordon |
| Title | Mastering and Managing the FDA Maze |
| Place, publisher, and date of publication | La Vergne : ASQ Quality Press,c2014 |
| International Standard Book Number | 9780873898874 |
| 797 2# - LOCAL ADDED ENTRY--CORPORATE NAME (RLIN) | |
| Corporate name or jurisdiction name as entry element | ProQuest (Firm) |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://ebookcentral.proquest.com/lib/orpp/detail.action?docID=7158793">https://ebookcentral.proquest.com/lib/orpp/detail.action?docID=7158793</a> |
| Public note | Click to View |
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