This chapter is taken from the book Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume 2
A well-accepted premise in the pharmaceutical/biopharma industry is that the most significant source of contamination when making a sterile product is people.
It is a bit ironic then, that people — who most firms regard as their most important asset — are also the most significant risk to patients dosage forms that must be
essentially free from viable (e.g., bacteria and molds) and nonviable (e.g., fibers, glass shards, and dusts) particulates.
In this chapter, we will examine a variety of ways that training and performance-supporting activities can be used to minimize the negative impact
and maximize the benefits that personnel can have as they produce or support the production of sterile pharmaceutical products.
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Table of Contents:Why Focus on People?
The Right People for the Job
Equipping the Person to do the Job, Part 1: Defining the Competencies
Equipping the Person to do the Job, Part 2: Providing Knowledge and Skills
Creating Learning Plans (Curricula)
Topics to Include in the Curricula
Assessment of Learner Knowledge and Performance
Learning From Successes and Failures
Appendix One: Examples of Regulatory Requirements on Training and Personnel
About the Authors
Vesper designs and develops instructional courses and workshops for the
pharmaceutical industry. He established and is president of the firm,
LearningPlus, Inc., and has had more than 25 years experience in the
pharmaceutical industry. Mr. Vesper worked eleven years at Eli Lilly and
Company, Indianapolis. His last assignment was as 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 around the world 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. An as author, his newest of five books, Risk
Assessment and Risk Management in the Pharmaceutical Industry, was published
in 2006 by PDA/DHI Publications. Mr. Vesper earned a B.S. in Biology from
Wheaton (Illinois) College and a Masters of Public Health from the University of
Michigan School of Public Health in Ann Arbor.