Cost-Contained Regulatory Compliance: For the Pharmaceutical, Biologics, and Medical Device Industries...

— —

Sandy Weinberg

Cost-Contained Regulatory Compliance

Name: Cost-Contained Regulatory Compliance
Price: 248.78 AUD
Availability: OutOfStock
ISBN: 9780470552353

For the Pharmaceutical, Biologics, and Medical Device Industries

Sandy Weinberg

$310.95 $248.78

Hardback

Not in-store but you can order this
How long will it take?

Availability Information

We source books from suppliers in Australia and overseas. For books we don't currently have in stock, the time it takes to get them from our suppliers can vary widely - from a few days to a few months - so we check each book with each supplier to determine the expected time it will take to be supplied to us.

We will update you on expected arrival time to us. If this delay is too long, please let us know within 2 business days and we can give you options regarding cancelling or adjusting your order. More details on cancelling your order can be found in our Terms of Trade.

To find out the anticipated arrival time for specific items prior to ordering, please contact us by phone or email:

Phone +61 2 9264 3111, or 1800 4 BOOKS (1800 4 26657) if outside Sydney:
option 1 Abbey's Bookshop (Crime, History, Science, Kids & more) • info@abbeys.com.au
option 2 Language Book Centre (ESL & Foreign Languages) • language@abbeys.com.au
option 3 Galaxy Bookshop (Sci-fi, Fantasy, Romance, Graphic Novels) • sf@galaxybooks.com.au

QTY:

English

John Wiley & Sons Inc
20 April 2011

Pharmaceutical industries; Pharmacology; Pharmaceutical technology

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.

By: Sandy Weinberg
Imprint: John Wiley & Sons Inc
Country of Publication: United States
Dimensions: Height: 243mm, Width: 161mm, Spine: 21mm
Weight: 590g
ISBN: 9780470552353
ISBN 10: 0470552352
Pages: 296
Publication Date: 20 April 2011
Audience: Professional and scholarly , Undergraduate
Format: Hardback
Publisher's Status: Active

PREFACE. Chapter 1. Controlling Regulatory Costs. Chapter 2. Clear Operation Definitions of Requirements. Chapter 3. Pre-Regulatory Audits. Chapter 4. Quality by Design. Chapter 5. Outsourcing. Chapter 6. Electronic Submissions. Chapter 7. EMEA/FDA Inspections. Chapter 8. Managing FDA Inspections. Chapter 9. Risk Assessment. Chapter 10. Cases. Chapter 11. Cost Containment Analysis. Chapter 12. Managing Regulation In Times of Chaos. Chapter 13. International Regulation. Chapter 14. Cost Contained Regulatory Compliance. Chapter 15. Future. BIBLIOGRAPHY. INDEX .

SANDY WEINBERG, PhD, is a professor of healthcare management at Clayton State University in Atlanta and an international regulatory consultant. He has thirty-five years' regulatory experience, including global executive responsibility at GE Healthcare and Tikvah Therapeutics. Dr. Weinberg has written thirteen books including, most recently, Guidebook for Drug Regulatory Submissions, also from Wiley.