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|a EBLCP
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|a 9781636940465
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|a 1636940463
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|a 344.7304/1--dc23
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|a UAMI
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| 100 |
1 |
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|a Harnack, Gordon.
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| 245 |
1 |
0 |
|a Mastering and Managing the FDA Maze
|h [electronic resource] :
|b Medical Device Overview.
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| 250 |
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|a 2nd ed.
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| 260 |
|
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|a La Vergne :
|b ASQ Quality Press,
|c 2014.
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| 300 |
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|a 1 online resource (501 p.)
|
| 336 |
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|a text
|b txt
|2 rdacontent
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| 337 |
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|a computer
|b c
|2 rdamedia
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| 338 |
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|a online resource
|b cr
|2 rdacarrier
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| 500 |
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|a Description based upon print version of record.
|
| 505 |
0 |
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|a 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
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| 505 |
8 |
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|a 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
|
| 505 |
8 |
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|a 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
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| 505 |
8 |
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|a Device Labeling -- Subpart K-Labeling and Packaging Control -- FDA Inspection of Labeling -- Packaging -- 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)
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| 505 |
8 |
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|a 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
|
| 500 |
|
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|a FDA Accredited UDI Organizations
|
| 590 |
|
|
|a ProQuest Ebook Central
|b Ebook Central Academic Complete
|
| 610 |
1 |
0 |
|a United States.
|t Food and Drug Administration Safety and Innovation Act.
|
| 630 |
0 |
7 |
|a Food and Drug Administration Safety and Innovation Act (United States)
|2 fast
|
| 650 |
|
0 |
|a Medical instruments and apparatus
|x Safety regulations
|z United States.
|
| 650 |
|
6 |
|a Médecine
|x Appareils et instruments
|x Sécurité
|x Règlements
|z États-Unis.
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| 650 |
|
7 |
|a Medical instruments and apparatus
|x Safety regulations
|2 fast
|
| 651 |
|
7 |
|a United States
|2 fast
|1 https://id.oclc.org/worldcat/entity/E39PBJtxgQXMWqmjMjjwXRHgrq
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| 758 |
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|i has work:
|a Mastering and managing the FDA maze (Text)
|1 https://id.oclc.org/worldcat/entity/E39PCGmVt8bPqFKt7xV86KXwFq
|4 https://id.oclc.org/worldcat/ontology/hasWork
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| 776 |
0 |
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|i Print version:
|a Harnack, Gordon
|t Mastering and Managing the FDA Maze
|d La Vergne : ASQ Quality Press,c2014
|z 9780873898874
|
| 856 |
4 |
0 |
|u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=7158793
|z Texto completo
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|a ProQuest Ebook Central
|b EBLB
|n EBL7158793
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