PDA 450.1 Learning, Knowledge Management and Impact: Moving from Theory to Practice

The ICH Q10 Pharmaceutical Quality Systems document, FDA, other national authorities, and industry experts identified that knowledge management is an enabler – a foundation – to a modern pharmaceutical quality system. The current practices of training across the industry are limited in how they contribute to knowledge management. As a result, a growing number of firms and organizations are changing their focus from “training” to looking at “learning” as a way of sharing knowledge and developing their people. Changing this point of view is more than just words – it must involve a change in perspective of doing things differently. This movement, from training to learning, comes at the same time when our industry is trying to better understand knowledge management and how this contributes to process understanding, human performance, and product quality.

In this live eLearning training course, key theories that describe knowledge management and how people as well as organizations learn will be examined. Using these theories, participants will find ways to apply them to some of the practical challenges faced in the pharmaceutical/biopharmaceutical industry, such as knowledge acquisition and transfer, procedure writing and training, new employee on-boarding, web-based learning, and structured on-the-job training. A portion of this workshop will involve identifying best practices, both inside the industry and beyond, and reimagining what can be done differently.

1. Describe knowledge management, emphasizing the roles of individual and organizational learning
2. Describe four learning theories and their practical implications
3. Identify regulatory expectations for training and performance
4. Develop alternative approaches to knowledge transfer that are grounded in good learning practices and meet regulatory expectations
5. Discuss different models for assessing and evaluating learning and learning programs
6. Identify ways that learning and impact can be evaluated given alternative approaches for learning