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The book contains many new practical tips, tools and case studies that will allow validation scientists and management to make good risk-based decisions during planning, execution and post-implementation changes for all projects. This book is centered on what “sufficient performance” and “suitable for use” really mean for analytical methods. Dr. Krause will also answer the question, how can we measure risk and control this risk using well-designed validation studies. Currently, regulatory guidelines provide only basic guidance for analytical method validation. Dr. Krause’s work builds on these basic regulatory guidance documents and provides several detailed validation practices, discussions and case studies on the best-possible strategies to assist readers to make good decisions.

“After reading this book, I felt a bright light was focused on many of the items that I once considered hidden in a 'black box.' I encourage development and validation scientists as well as quality and regulatory managers to read this thought provoking book to better understand how to effectively monitor your production processes and the quality of your products. It will also allow you to prepare quicker and more robust regulatory filings. I hope you enjoy the work in this book as much as I have.”
Martin VanTrieste,
Chairman of PDA’s Scientific Advisory Board,
VP Quality, Commercial Operations, Amgen, Inc.

Table of Contents:

Click here to download Table of contents

Preface
Introduction (Click here to download Introduction)
Acknowledgements
1. Breaking It Down Into Pieces
2. Analytical Method Development (AMD)
3. Analytical Method Validation (AMV)
4. Acceptance Criteria
5. Analytical Method Comparability (AMC)
6. Analytical Method Transfer (AMT)
7. Analytical Method Maintenance (AMM)
8. Dealing with Validation Failures
List of Acronyms
Index

Click here to read the Review by Mareike Viebahn, PhD, Centocor BV

Stephan O. Krause, PhD has a doctoral degree in analytical biochemistry from the University of Southern California and has been involved with analytical method validation for over eight years. Stephan has held leading roles in the area of analytical testing and validation for several pharmaceutical and biopharmaceutical firms in California. He is currently the Director of Quality Control at a biotech firm in San Diego, California.

Stephan is a popular lecturer and author. He has published more than a dozen articles on the topic of analytical method validation in highly respected industry journals. He often serves as session chair and lecturer at major conferences and also serves on several Editorial and Scientific Advisory Boards.

PDA/DHI Publication