A message from the author of

Risk Assessment and Risk Management in the Pharmaceutical Industry

James L. Vesper

Each of us use risk management on a daily basis. Whether it involves selecting the route
to work that has the least traffic, picking the airline that has the best chance for getting
you to your destination on time (and with your luggage), or determining how much time
to spend on the beach, risk management is involved.

Risk management, then, is a tool to help us make decisions when there is some potential
of a hazard being expressed that could result in harm or some sort of unwanted incident.

Most of the time when we make risk-based decisions, we use an informal method –
heuristics – generating perceptions and judgments that we may not consciously be aware
of.

Regulatory agencies like the FDA and bodies like the International Conference on
Harmonization (ICH) are encouraging the pharmaceutical and biopharma industry to use
risk management in a more formalized, documented way. We have been using risk
management, for example in change control or when performing GMP/quality audits of
suppliers, but as an industry, we are far behind other industries (e.g., nuclear power and
aviation) and sectors (e.g., worker safety and environmental protection) which have been
using formalized risk management for decades.

The whole topic of risk management and risk assessment is a fascinating area of study
that I have been involved with in different ways throughout my career in the industry.
This book shares what I have found most interesting and useful about the risk
management process, the tools used to identify hazards and assess risks, ways to control
risks, and some fascinating facts related to risk-based thinking. (What do Galileo, steam
engines, and a coffee shop in London have to do with the history of risks? In the first
chapter, “An Incomplete History of Risk Management” you’ll find the answer.)

The book also looks at five of the most frequently used tools for risk assessment as well
as the HACCP process – a method that was developed to reduce risks in the food
industry.

www.pda.org/bookstore
If you are new to the field of risk management, a member of a risk-assessment team, or
someone wanting to implement formalized risk-based thinking in your organization, I
believe you’ll find this a very useful book.

Jim.

James L. Vesper

www.pda.org/bookstore