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

Format:

Book

Author/Creator:

Weinberg, Sandy, 1950-

Language:

English

Subjects (All):

Medical instruments and apparatus industry--United States--Cost control.

Medical instruments and apparatus industry.

Medical instruments and apparatus--Inspection--United States.

Medical instruments and apparatus.

Pharmaceutical industry--United States--Cost control.

Pharmaceutical industry.

Pharmaceutical industry--Inspection--United States.

United States. Food and Drug Administration.

United States.

Physical Description:

1 online resource (296 p.)

Edition:

1st ed.

Place of Publication:

Hoboken, N.J. : John Wiley & Sons, c2011.

Language Note:

English

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.

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.

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

Description based on metadata supplied by the publisher and other sources.

ISBN:

9786613025609

9781118002278

111800227X

9781283025607

1283025604

9780470933503

047093350X

9780470933510

0470933518

OCLC:

711780339