Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics,9780824740788

Compliance Handbook for Pharmaceuticals, Medical Devices, and Biologics

by ;
ISBN13: 9780824740788
ISBN10: 0824740785
Format: Hardcover
Pub. Date: 2003-12-09
Publisher(s): CRC Press
List Price: $210.00

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Summary

Lists the necessary steps for meeting compliance requirements during the drug development process. Presents comprehensive approaches for validating analytical methods for pharmaceutical applications. Features key discussions on pre-approval inspections.

Table of Contents

Preface v
Introduction ix
Contributors xvii
1. Regulatory Submissions
1(64)
Patricia Fritz and Anisa Dhalla
2. Compliance Requirements During the Drug Development Process
65(18)
Martin D. Hynes III
3. Validation: A New Perspective
83(46)
James Agalloco
4. Validating Analytical Methods for Pharmaceutical Applications: A Comprehensive Approach
129(56)
Paul A. Winslow and Richard F. Meyer
5. The Stability Testing Program
185(38)
Maria A. Geigel
6. Computer Validation: A Compliance Focus
223(28)
Timothy Horgan and Timothy Carey
7. Compliance Issues Associated with Cleaning in the Pharmaceutical Industry
251(34)
William E. Hall
8. The Batch Record: A Blueprint for Quality and Compliance
285(30)
Troy Fugate
9. Change Management: A Far-Reaching, Comprehensive, and Integrated System
315(32)
Susan Freeman
10. The Vendor Qualification Program 347(26)
Elizabeth M. Troll and Karen L. Hughes
11. Handling Laboratory and Manufacturing Deviations 373(56)
Robert B. Kirsch
12. The Internal Audit Program: A Quality Assessment 429(34)
Graham Bunn
13. Preapproval Inspections: The Critical Compliance Path to Success 463(30)
Martin D. Hynes III and Carmen Medina
14. The Impact of Total Quality Performance on Compliance 493(60)
Carmen Medea
15. International Compliance Issues and Trends 553(30)
Alan G. Minsk
16. Strategic Planning for Compliance and Regulatory Defensiveness 583(22)
Ron Johnson
17. Unique and Unprecedented Compliance Challenges in the Biologics Arena 605(42)
Anne P. Hoppe and Curtis L. Scribner
Index 647

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