Risk Assessment and Risk Management in the Pharmaceutical Industry: Clear and Simple (single user digital version)
- Published
- Jan 2015
- ISBN
- 1-930114-90-7
- Pages
- 298
- PDA Item Number
- 17995
- Format
- PDF Single user
- Member Price
- $204.00
- Nonmember Price
- $255.00
- Government Price
- $128.00
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Risk Assessment and Risk Management in the Pharmaceutical Industry: Clear
and Simple, 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".
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here to read a message from the author
Book written in June, 2006
Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 3.61 MB)
Hardcover book is not available.
Table of Contents
Table of Contents:
Click here to download >>> Detailed 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
About the Authors
About the Authors
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, Fourth Edition, becomes one of the best sellers of PDA/DHI,
co-published books.