1st Edition
Good Drug Regulatory Practices A Regulatory Affairs Quality Manual
By Helene I. Dumitriu
Copyright 1997
440 Pages
by
CRC Press
440 Pages
by
CRC Press
Good Drug Regulatory Practices offers a series of policies and procedures to assure quality and timely regulatory submissions to national regulatory agencies. This book begins with introductory chapters describing the need for policy documentation, and the philosophy underlying the policies, and presents policies and standards that can be used as presented or adapted to individual situations in... Read more
Part I: The Regulatory Affairs Quality System 1. Historical Overview 2. Good Regulatory Practice: The Application of Quality Management to Regulatory Affairs 3. Check Your Quality System Part II: The Regulatory Affairs Quality Manual 4. The Quality Manual Explained 5. The Philosophy behind the Policies 6. Policies 7. Standards
Biography
Dumitriu, Helene I.
