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OCoLC |
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20240329122006.0 |
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m o d |
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230107s2021 xx o ||| 0 eng d |
| 040 |
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|a EBLCP
|b eng
|c EBLCP
|d REDDC
|d OCLCF
|d OCLCO
|d OCLCQ
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| 020 |
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|a 9781951058371
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| 020 |
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|a 1951058372
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| 035 |
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|a (OCoLC)1356002209
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| 050 |
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4 |
|a R856.6 A77 2021
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| 082 |
0 |
4 |
|a 610.28--dc23
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| 049 |
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|a UAMI
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| 100 |
1 |
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|a Laman, Scott A.
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| 245 |
1 |
4 |
|a The ASQ Certified Medical Device Auditor Handbook
|h [electronic resource].
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| 250 |
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|a 4th ed.
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| 260 |
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|a La Vergne :
|b ASQ Quality Press,
|c 2021.
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| 300 |
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|a 1 online resource (373 p.)
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| 500 |
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|a Description based upon print version of record.
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| 505 |
0 |
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|a Cover -- Title page -- CIP data -- Table of Contents -- Preface -- Acknowledgments -- Part I_Auditing -- Chapter 1_Auditing Fundamentals -- Audits by Purpose -- Audits by Method -- Audit Roles and Responsibilities -- Professional Conduct and Responsibilities -- Legal Consequences and Liability -- Data Privacy -- Chapter 2_Auditing and Inspection Processes -- Audit Preparation and Planning -- Audit Performance -- Audit Reporting -- Audit Follow-Up and Closure -- Data Integrity Principles -- ALCOA -- Chapter 3_Audit Procedural References -- ISO 19011:2018
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| 505 |
8 |
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|a Medical Device Single Audit Program (MDSAP) -- Quality System Inspection Technique (QSIT) -- FDA Compliance Program Guidance Manual (CPGM) 7382.845 -- Part II_Medical Device Quality Management System Requirements -- Chapter 4_FDA-Code of Federal Regulations (CFR) Title 21 -- Code of Federal Regulations (CFR) -- 21 CFR 4 Current Good Manufacturing Practice Requirements for Combination Products -- 21 CFR 7 Enforcement Policy -- 21 CFR 11 Electronic Records -- Electronic Signatures -- 21 CFR 58 Good Laboratory Practice for Nonclinical Laboratory Studies -- 21 CFR 801 Labeling
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| 505 |
8 |
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|a 21 CFR 803 Medical Device Reporting -- 21 CFR 806 Corrections and Removals -- 21 CFR 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices -- 21 CFR 807 Subpart E-Premarket Notification Procedures -- 21 CFR 820 Quality System Regulation -- 21 CFR 821 Medical Device Tracking Requirements -- 21 CFR 830 Unique Device Identification -- Chapter 5_U.S. Requirements (FD&C Act, 201, 301-304, 501-502, 510, 513, 518, 522, 704) -- Introduction -- FD&C Act Chapter II: Definitions -- FD&C Act Chapter III: Prohibited Acts and Penalties
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| 505 |
8 |
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|a FD&C Act Chapter V: Drugs and Devices -- FD&C Act Chapter VII: General Authority -- Chapter 6_The EU Medical Device Regulation -- Introduction -- The MDD to MDR Transition -- Scope and Purpose of the Medical Device Regulation -- Requirements for Compliance -- Determining Whether the Product Must Comply with the Regulation -- Types of Medical Devices -- Classification of Medical Devices -- Quality Management Systems, Processes, and Resources for Medical Devices -- Safety and Performance Requirements -- Risk Management -- Clinical Evaluation -- Technical Documentation -- Distribution
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| 505 |
8 |
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|a Device and Manufacturer Registration -- Conformity Assessment -- CE Marking -- Market Launch -- Post-Market Launch and Maintenance -- Summary -- Chapter 7_Other International Regulations -- Introduction -- Canada -- Japan -- Australia -- Brazil -- China -- Chapter 8_Requirements for In Vitro Diagnostic (IVD) Devices -- Introduction -- 21 CFR 809 -- FDA-Recognized Standards -- IVDR 2017/746 -- Chapter 9_International Standards for Quality Systems -- ISO 9001 -- ISO 13485 -- ISO/IEC 17025 -- Chapter 10_Quality System Regulation (QSR) Requirements -- Introduction -- Preamble -- General Provisions
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| 500 |
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|a Quality System Requirements
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| 590 |
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|a ProQuest Ebook Central
|b Ebook Central Academic Complete
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| 650 |
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0 |
|a Auditing
|v Handbooks, manuals, etc.
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| 650 |
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0 |
|a Auditing
|x Mathematical models.
|
| 650 |
|
7 |
|a Auditing
|2 fast
|
| 650 |
|
7 |
|a Auditing
|x Mathematical models
|2 fast
|
| 655 |
|
7 |
|a Handbooks and manuals
|2 fast
|
| 776 |
0 |
8 |
|i Print version:
|a Laman, Scott A.
|t The ASQ Certified Medical Device Auditor Handbook
|d La Vergne : ASQ Quality Press,c2021
|z 9781951058357
|
| 856 |
4 |
0 |
|u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=7158738
|z Texto completo
|
| 938 |
|
|
|a ProQuest Ebook Central
|b EBLB
|n EBL7158738
|
| 994 |
|
|
|a 92
|b IZTAP
|
