Mastering And Managing The Fda Maze

Author: Gordon Harnack
Publisher: ASQ Quality Press
ISBN: 9780873894555
Size: 42.88 MB
Format: PDF, Docs
View: 3992
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Graphic icons organize the text and provide a visual aid to definitions, regulations, procedures, documents, records, and points to remember.

Iso 13485

Author: Itay Abuhav
Publisher: CRC Press
ISBN: 1439866112
Size: 37.21 MB
Format: PDF, ePub, Mobi
View: 6389
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Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 Standard certification for medical device manufacturing.

The Certified Pharmaceutical Gmp Professional Handbook Second Edition

Author: Mark Allen Durivage
Publisher: ASQ Quality Press
ISBN: 0873899334
Size: 32.80 MB
Format: PDF, ePub
View: 978
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Also available from ASQ Quality Press: Handbook of Investigation and Effective
CAPA Systems, Second Edition José RodríguezPérez Statistical Process Control
for the FDARegulated Industry Manuel E. PeñaRodríguez The FDA and
Worldwide ... Document Control System for Compliance with ISO 9001:2015, ISO
13485:2016, and FDA Requirements Stephanie L. Skipper The FDA and
Worldwide Quality System Requirements Guidebook for Medical Devices,
Second Edition Amiram ...

Medical Device Design And Regulation

Author: Carl T. DeMarco
Publisher: ASQ Quality Press
ISBN: 0873898168
Size: 75.58 MB
Format: PDF, Docs
View: 6832
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Also available from ASQ Quality Press: The FDA and Worldwide Quality System
Requirements Guidebook for Medical Devices, Second Edition Amiram Daniel
and Ed Kimmelman CAPA for the FDA-Regulated Industry José Rodríguez-Pérez
Development of FDA-Regulated Medical Products: Prescription Drugs, Biologics,
and Medical Devices Elaine Whitmore Safe and Sound Software: Creating an
Efficient and Effective Quality System for Software Medical Device Organizations
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