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Synopsis
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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About the Author
Dr. Richard Prince is Senior Director, Regulatory Affairs, Quality & Clinical Operations, Immunomedics, Inc., a biotechnology firm located in New Jersey, USA. He has twenty-two years experience in the industry with previous positions in general scientific management, business development, microbiological and toxicological laboratory operations, corporate quality assurance, GXP regulatory compliance and, most recently, in regulatory affairs and clinical operations. Dr. Prince, with this work, has now published four textbooks for the PDA/DHI Books in the areas of microbiology, quality and confronting variability.
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.
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Confronting Variability: A Framework for Risk Assessment
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