Training of Aseptic Processing Personnel (single user digital version)

Feb 2008
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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

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
  • Instructional Methods
  • Periodic/Reinforcement Training
  • Assessment of Learner Knowledge and Performance
  • Qualification? Certification?
  • Learning From Successes and Failures
  • Conclusion
  • Acknowledgements
  • References
  • Appendix One: Examples of Regulatory Requirements on Training and Personnel
  • About the Authors

    About the Authors

    James L. 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.