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GMP-Fachbücher

Risk Assessment and Risk Management in the Pharmaceutical Industry
€ 223,00
netto
€ 238,61
inkl. 7% MwSt.
Clear and Simple
Auflage: June 2006
292 Seiten
ISBN: 1-930114-90-7
This book begins with history, definitions, how we think about risks and hazards, it gives overview of the risk management process and commonly used risk assessment methods and tools. It also explores the phases of the risk management process in detail and examines how the various tools can be applied in identifying hazards and evaluating their potential impact and affects. There are examples throughout the book that illustrate how the tools can be applied in "real life".

Table of Contents:
Click here to download Table of contents
Preface
Acknowledgements
Introduction
Chapter 1 - A Incomplete History of Risk Management (Click here to download Chapter 1)
Chapter 2 - Hazards and risks: Concepts and definitions of important terms
Chapter 3 - Risks: Perceptions versus reality
Chapter 4 - Accident theory
Chapter 5 - An overview of the risk management process
Chapter 6 - Communication
Chapter 7 - An overview of risk assessment tools
Chapter 8 - Evaluation
Chapter 9 - Control
Chapter 10 - Monitoring
Chapter 11 - Risk related documentation and records
Chapter 12 - A detailed look at Hazard Analysis and Critical Control Points (HACCP)
Chapter 13 - A detailed look at Preliminary Risk Analysis (PRA)
Chapter 14 - A detailed look at Failure Modes, Effects and Criticality Analysis (FMECA)
Chapter 15 - A detailed look at Hazard Operations Analysis (HAZOPS)
Chapter 16 - A detailed look at Fault Tree Analysis (FTA)
Chapter 17 - A detailed look at Event Tree Analysis (ETA)
Chapter 18 - Auditing a risk management program
Chapter 19 - The organization and risk management
Appendices: Examples

"This book defines risk, discusses hazards and risks, and provides tools to evaluate risk, while providing the background and context necessary to understand the concept of risk management detailed in the regulatory guidance documents and to develop effective strategies for dealing with risk in the pharmaceutical industry."
Russell E. Madsen, President
The Williamsburg Group, LLC, Gaithersburg, Maryland
James L. Vesper designs and develops instructional courses and workshops for the pharmaceutical and medical device industries. He established and is president of the firm, LearningPlus, Inc. and has had more than 25 years of experience in the pharmaceutical industry. Mr. Vesper worked eleven years at Eli Lilly and Company, Indianapolis. His last assignment there was Project Leader of GMP (Good Manufacturing Practice) Education and Instruction, establishing the department and its mission.

Since 1991, Mr. Vesper has been creating innovative instructional products for pharmaceutical firms using leader-led, video, and computer technologies as more effective and efficient delivery media. Working as consultants with a wide variety of clients, his firm creates integrated curricula for personnel and customized training courses targeted to particular needs. He provides workshops at various international technical and professional meetings. In 2001, he was awarded the PDA`s Agallaco Award for Excellence in Training. He is also the author of GMP in Practice, Third Edition, becomes one of the best sellers of PDA/DHI, co-published books.
PDA/DHI Publication