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Books by LearningPlus founder James L. Vesper

Training for the Healthcare Manufacturing Industries

Training is one of the most important -- and costly -- investments an organization can make. Focusing on employee performance and using a systematic approach to design, develop, deliver, and measure effectiveness of instruction can optimize the training investment. 

This book examines topics related to training, adult learning, human performance, multimedia, new training technologies, and compliance issues, all from a healthcare manufacturing industry perspective. A step-by-step approach to instructional system design provides for highly effective instructional programs.

Written by a practitioner and designed for departmental supervisors and managers providing on-the-job training, this book offers proven tools and techniques for planning, implementing, and measuring training programs that work.

 

Training for Healthcare Manufacturing Industries

Preface

It was a phone call that started all of this: my manager called me while I was working in France and asked if I would establish a corporate group to develop training programs on the U.S. FDA's Current Good Manufacturing Practice regulations (cGMPs) and the company's standard operating procedures. Maybe it was because I had taught several "standup," leader-led programs or had taught at Indiana University, or maybe because I had been labeled a "creative" type -- I'm still not sure. But, as they say, it was an opportunity I couldn't refuse.

Entering into the task, I encountered professions and jargon I had never known: instructional designers, instructional technologists, front-end analysis, mastery learning -- the list could go on and on. But what was exciting was getting a glimpse of how different training could be if approached from the perspective of human performance. It was there and then I discovered that "training" was much more complex than I had been told or had experienced.

Despite the complexity, there was a simplicity in the goal: getting a person or persons to perform tasks safely, correctly, and effectively, time after time.

In trying to understand and deal with this seeming paradox, I began reading about human performance, adult learning theory, and what other industries were and are doing in instructing and training their employees. I discovered a variety of ways to deliver instruction, some of which have been around for generations and others just now becoming practical and useful.

Also, I began talking with and visiting other pharmaceutical and medical device firms to learn and share approaches, tools, frustrations, and ideas.

And yes, I talked with some of the users of training programs to learn what they liked, what they did not like, and how they thought learning could be best be integrated into their operational or professional activities.

This book is the result of the learning and experiences I have had regarding training and performance since receiving that phone call in September 1989. It is a book I wish I had had when I started that job.

Several people to whom I have described this project have said, "Oh . . . it's going to be a cookbook for doing training." I think it all depends on what you mean by "cookbook."

There is a cook who comes to mind who meticulously follows a recipe. Her use of timers, thermometers, and measuring cups would make the director of the National Bureau of Standards proud. Her successes, though frequent, are uninspired. A crisis occurs when she discovers there are only two cups of flour and she needs three, or when the sauce breaks down and separates into globules even though she followed the recipe precisely. Variations and surprises throw her into turmoil.

Another person comes to mind -- my father. Raised in his family's bakery and studying the subject in college, he learned that recipes were guides. Temperature and humidity were factors to be reckoned with just as the time in the oven. He learned there are rules of thumb about what you can substitute if you run out of a particular item. If you discovered you were out of flour, that gave you the opportunity to try something else. Occasionally it did not work, but most of the time, the results were sensational.

The point is this: if you try to use this volume as a step-by-step, do-it-without-thinking cookbook, you will succeed to a limited degree. But, if you understand the concepts and principles, and apply them to your specific situation with creativity and courage, using this book as a guide, you will do far better.

Getting the best and most from the people who are doing a particular job is not a validated process. Neither is producing a training course or lesson that will yield optimal results on the first (or second or third) try. There are, however, some guidelines and approaches that will greatly increase the probability of success. If you understand something about how people -- adults -- learn, how to systematically define the problem and how to solve it, the learner's needs and how to meet them, you'll be 80 percent there. The more frequently you do it, the more you will learn, and the better the results.

There is science and technology involved in training, but there is also some art. You are fighting for the attention and concentration of people who usually would rather be elsewhere, doing almost anything. Creatively developed and visually appealing handouts, engaging computer-based training, videos, slides, or the use of a well-told story in any medium can help get people to focus on the knowledge and skills you are helping to provide to them.

Julia Child, one of America's greatest chefs, with her co-authors wrote:

Cooking is not a particularly difficult art, and the more you cook and learn about cooking, the more sense it makes. But like any art it requires practice and experience. The most important ingredient you can bring to it is love of cooking for its own sake.

Change the verb from "cook" to "teach" or "train," add some rigor and technology, mix well, and there you have it.

There is a basic model of instructional systems design, with as many variations as practitioners, used to systematically produce a "training intervention." The approach you will find here is a mix of (what I have found to be) the best of the variations, plus some new ideas, realism, and experience gained while working for a large pharmaceutical corporation and, more recently, consulting in the U.S. and abroad. Included are examples or situations where people (including me) have learned something from the College of Painful Experience.

This book will not make you an instructional designer or a performance technologist; it does not intend to do that. This book should help you make 80 percent of your training programs 80 percent more effective than what one professional calls the "spray and pray" approach to training. To go much beyond that 80/80 estimate, and for complex or unusual projects, you will need the experience, expertise, and unique perspective of professional instructional designers.

If you have an opportunity to be involved with training and human performance, you are very fortunate. You will learn an incredible amount about people, various topics, and using a systematic process for solving problems that will help you in every other position that you will have. You will make a difference in the lives of people and in the quality of your firm's products and in the company's profitability.

And, if you do it right, you will also have a whole lot of fun.

Jim Vesper
June 1993
Rochester, New York

Table of Contents

vii Preface
xi Acknowledgements
xiii Introduction
1 Section I: Before You Begin ...
3 1. Why Training Is Not the Answer
9 2. Focusing on Human Performance
21 3. Training as a Way to Improve Human Performance
27 4. Training and the Organization
41 5. Regulatory Compliance: The Minimal Goal
57 6. How Adults Learn Best
65 7. Overview of the Instructional Systems Design Process
73 Section II: Analysis Phase
75 8. Introduction to the Analysis Phase
77 9. Define the Scope of the Project
81 10. Analyze the Job
85 11. Analyze the Tasks
95 12. Analyze Audience Characteristics
101 13. Summarize the Findings
105 14. Check Quality
107 15. Prioritize Needs
111 Section III: Design Phase
113 16. Introduction to the Design Phase
119 17. Consider What Else Is Needed
123 18. Establish and Confirm Program Goal
127 19. Identify the Subgoals
131 20. Establish the Objectives
137 21. Select Topics to be Included in the Instructional Unit
141 22. Develop Manageable Units of Instruction
143 23. Plan the Evaluation Strategy
151 24. Prepare a High-Level Outline
165 25. Select the Appropriate Instructional Methods
175 26. Select the Appropriate Media
191 27. Identify Potential Instructors and Monitors
195 28. Refine the Curriculum
199 29. Check Quality
201 30. Prepare the Written Instructional Plan and Have it Approved
205 Section IV: Development Phase
207 31. Introduction to the Development Phase
211 32. Expand the Instructional Outline
219 33. Sketch or Story board Visuals and Other Materials
225 34. Check Quality
227 35. Plan Implementation and Rollout
231 36. Develop Lessons and Activities
237 37. Develop Evaluation Methods and Tools
247 38. Produce Visuals and Other Instructional Materials
257 39. Prepare the Instructor's Manual
259 40. Conduct a Pilot Program and Modify Course / Lessons as Needed
263 41. Approve the Course
267 Section V: Implementation Phase
269 42. Introduction to the Implementation Phase
271 43. Prepare Instructors and Monitors
277 44. Schedule Sessions, Instructors, and Participants
279 45. Deliver the Course
281 46. Document Attendance
285 47. Document Instructional Content and Materials
287 48. Collect and Assess Evaluation Data
291 Section VI: Evaluation and Maintenance Phase
293 49. Introduction to Evaluation and Maintenance Phase
297 50. Analyze Evaluation Data and Modify the Course as Needed
301 51. Coach Instructors as Needed
307 52. Measure Course Effectiveness
309 Section VII: Related Topics
311 53. Deciding to Build or Buy Courses or Instructional Materials
317 54. Using Outside Professionals
325 55. Having and Using Procedures
335 56. Auditing Human Performance and Training Programs
343 57. Transferring Programs and Courses Abroad
355 Section VIII: Looking into the Future
357 58. The Changing Audience
363 59. Using Multimedia Technology
373 60. Electronic Performance Support Systems
383 61. Virtual Reality as a Training Tool
389 Appendices
391 A. European Community Training Requirements for Pharmaceutical Personnel
395 B. Resources
399 References and Sources
407 Index



 
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