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Books by LearningPlus founder James L. Vesper

Risk Assessment and Risk Management in the Pharmaceutical Industry: Clear and Simple (2006)

Risk Assessment and Risk Management in the Pharmaceutical Industry: Clear and Simple outlines the history, definitions, and how we think about risks and hazards, and gives an overview of the risk management process and commonly use 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 effects.

"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, MD

 

Table of Contents

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



   
 
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