Confronting Variability: A Framework for Risk Assessment (Hardcover)
- Published
- Jan 2007
- ISBN
- 1-933722-04-5
- Pages
- 222
- PDA Item Number
- 17244
- Format
- Book
- Member Price
- $50.00
- Nonmember Price
- $50.00
- Government Price
- $50.00
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Variability is more than just the ‘noise in the system.’ It represents an insidious threat to companies, ranging from the reliability of their product lines to the strength of their financial bottom-lines. The understanding of variability sources, therefore, can provide a solid framework for risk assessment and an estimation of the impact these risks pose.
This book examines those elements of variability as they relate to people, processes, manufacturing systems, non-manufacturing systems, quality systems, laboratory systems, supply chains and GMP codes related to the pharmaceutical industry. It provides a new perspective on the meaning and relationship of variability in relation to work performed, as well as an insightful framework for the quality assessment of risk in the pharmaceutical industry.
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Table of Contents
Table of Contents:
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Preface
Introduction
(Click here to download >>>Introduction)
Chapter 1 - Simplifying Variability by
Davis Balestracci
Chapter 2 - People, Training and Variability by
Anne Marie Dixon
Chapter 3 - Variability in Manufacturing by
Vincent Sebald
Chapter 4 - Variability in Quality System Management
by Steve Kuwahara
Chapter 5 - Variability in the QC Laboratory by
Diane Petitti
Chapter 6 - Variability in Supply Chain Management by
Paul Seaback
Chapter 7 - Variability in Non-Manufacturing Functions
by Eileen Morrissey
Chapter 8 - GMP and Variability by Michael
H. Anisfeld
Index
About the Authors
About the Editors
Richard Prince, PhD is Director, Global Quality, for Mayne
Pharma, Inc. His previous work assignments included Microgen, Inc. (West
Caldwell, NJ), Richard Prince Associates, Inc. (Short Hills, NJ) and Gibraltar
Laboratories, Inc. (Fairfield, NJ). Prince has more than 21 years of experience
in the pharmaceutical and specialty chemical industries, specifically starting
up and/or working for product and service companies in executive capacities
ranging from scientific affairs to quality. He is also the editor of
Microbiology in Pharmaceutical Manufacturing and Pharmaceutical Quality.
Diane Petitti is a quality assurance professional
currently serving as Executive Director and Head of Quality for Amylin
Pharmaceuticals, Inc. (San Diego, CA). Her previous work assignments include
Roche Bioscience (Palo Alto, CA), Merck & Co., Inc. (West Point, PA), and
SmithKline and French Laboratories (Swedeland, PA). Petitti has more than 22
years of experience in the pharmaceutical and biotechnology industry within the
research and development, manufacturing, quality control and quality assurance
functional areas. Petitti has broad-based drug product exposure including small
molecules, peptides, proteins, and vaccines. Petitti has developed and
implemented comprehensive cGMP, GLP, and GCP Quality Systems in the drug and
device industry designed to ensure compliance to investigational and commercial
product quality standards.