PDA DHI Technical Books

Confronting Variability A Framework for Risk Assessment

Edited by: Richard Prince, Diane Petitti

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.


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 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.


Date of Publication: January 2007
ISBN Number: 1-933722-04-5
Format:
Number of Pages: 222
Binding: Hardcover