Regulatory Compliance

ISBN-13: 9780470552353 / Angielski / Twarda / 2011 / 296 str.

Sandy Weinberg

Opis

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.

Spis treści

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 .

O autorze

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.

Blurb

Proven strategies and case studies on how to contain regulatory costs in the healthcare industries

This book outlines a comprehensive strategy for controlling the cost of regulatory compliance in the pharmaceutical and medical industries. It provides professionals in the field with the tools they need to cut costs in submissions, compliance, and regulatory affairs while maintaining the quality and safety of their products.

Drawing on decades of regulatory experience, the author identifies eight field–tested strategies designed to eliminate redundancy, waste, uncertainty, inertia about regulatory guidelines, and other areas that add cost without adding value. He uses real–world case studies to illustrate the techniques, offering analysis and advice on implementation in different circumstances and industries. Copies of official documents from the FDA and other agencies are also included.

Readers will find no–nonsense, practical tips, and guidelines on how to:

• Clarify requirements to avoid overly zealous or "just to be safe" compliance that exceeds regulatory expectations

• Reduce FDA response and review time through independent audits and the adoption of electronic submissions

• Devise a simultaneous submission strategy to deal with FDA/EMA overlap

• Automate the quality control process through the use of Quality by Design (QbD) systems

• Use outsourcing in a constructive way to reduce overhead and tap outside expertise

• Take a proactive approach to FDA inspections and investigations and utilize risk–assessment management techniques