Cost-contained regulatory compliance : for the pharmaceutical, biologics, and medical device industries / Sandy Weinberg.

By:

Weinberg, Sandy, 1950-

Material type: Text

text

Media type:

computer

Carrier type:

online resource

ISBN:

9780470933503
047093350X
9780470933510
0470933518
9781118002278
111800227X
1283025604
9781283025607
9786613025609
6613025607
0470552352
9780470552353

Subject(s):

Genre/Form:

Additional physical formats: Print version:: Cost-contained regulatory compliance.DDC classification:

615.1068/1 22

LOC classification:

HD9994.U52 W45 2011eb

NLM classification:

2011 G-634
QV 736

Online resources:

Click here to access online

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.

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.

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Holdings
Item type	Home library	Collection	Call number	Materials specified	Status	Date due	Barcode
Electronic-Books	OPJGU Sonepat- Campus	E-Books EBSCO			Available

Includes bibliographical references (pages 273-277) and index.

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.