Coverart for item
The Resource Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries, Sandy Weinberg, (electronic resource)

Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries, Sandy Weinberg, (electronic resource)

Label
Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries
Title
Cost-contained regulatory compliance
Title remainder
for the pharmaceutical, biologics, and medical device industries
Statement of responsibility
Sandy Weinberg
Creator
Subject
Genre
Language
eng
Summary
This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations while maintaining product safety and improving public access through cost controls. It provides useful and practical guidance through industry case studies from pharmaceutical, biotech, and medical device industries
http://library.link/vocab/creatorDate
1950-
http://library.link/vocab/creatorName
Weinberg, Sandy
Dewey number
615.1068/1
Index
index present
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
http://library.link/vocab/subjectName
  • United States
  • Medical instruments and apparatus industry
  • Medical instruments and apparatus
  • Pharmaceutical industry
  • Pharmaceutical industry
  • United States. Food and Drug Administration
  • Pharmacy
  • Business
  • Medicine
  • Drug Industry
  • Biotechnology
  • Consumer Product Safety
  • Cost Control
  • Equipment and Supplies
  • Quality Assurance, Health Care
Label
Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries, Sandy Weinberg, (electronic resource)
Instantiates
Publication
Antecedent source
unknown
Bibliography note
Includes bibliographical references (pages 273-277) and index
Color
multicolored
Contents
Controlling regulatory costs -- Clear operation definitions of requirements -- Pre-regulatory audits -- Quality by design -- Outsourcing -- Electronic submissions -- Emea/fda coordination -- Managing FDA inspections -- Risk assessment -- Cases -- Cost containment analysis -- Managing regulation in times of chaos -- International regulation -- Cost contained regulatory compliance
Control code
ocn706476143
Dimensions
unknown
Extent
1 online resource (284 pages)
File format
unknown
Form of item
online
Isbn
9780470933510
Isbn Type
(electronic bk.)
Lccn
2010028410
Level of compression
unknown
Note
Wiley
Other control number
9786613025609
Quality assurance targets
not applicable
Reformatting quality
unknown
Sound
unknown sound
Specific material designation
remote
System control number
(OCoLC)706476143
Label
Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries, Sandy Weinberg, (electronic resource)
Publication
Antecedent source
unknown
Bibliography note
Includes bibliographical references (pages 273-277) and index
Color
multicolored
Contents
Controlling regulatory costs -- Clear operation definitions of requirements -- Pre-regulatory audits -- Quality by design -- Outsourcing -- Electronic submissions -- Emea/fda coordination -- Managing FDA inspections -- Risk assessment -- Cases -- Cost containment analysis -- Managing regulation in times of chaos -- International regulation -- Cost contained regulatory compliance
Control code
ocn706476143
Dimensions
unknown
Extent
1 online resource (284 pages)
File format
unknown
Form of item
online
Isbn
9780470933510
Isbn Type
(electronic bk.)
Lccn
2010028410
Level of compression
unknown
Note
Wiley
Other control number
9786613025609
Quality assurance targets
not applicable
Reformatting quality
unknown
Sound
unknown sound
Specific material designation
remote
System control number
(OCoLC)706476143

Library Locations

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