Learning, Knowledge Management, and Impact

Description

Knowledge management is considered a key enabler of a modern pharmaceutical quality system. This workshop provides participants practical ways of how training and learning contribute to a robust knowledge management program.

Designed as an advanced workshop, this two-day course examines the fundamentals of knowledge management and its practical aspects that contribute to product and process understanding.

Five learning theories are discussed along with how they can be used to support performance and create learning programs that are authentic learning opportunities. Participants use concept mapping as a way of reflecting on the topics covered and how they can be incorporated into their own organization.

Goal

Explore ways of moving from the traditional use of training to where learning, knowledge management, and process understanding contribute to better worker performance, compliant outcomes, and high-quality, pharmaceutical products & medical devices.

Objectives

• Describe knowledge management, emphasizing the roles of individual and organizational learning.
• Distinguish between “training” and “learning.”
• Develop alternative approaches to knowledge transfer that are grounded in good learning practices and meet regulatory expectations.
• Identify current expectations that regulatory agencies and auditors have of knowledge management, training systems, programs, and worker performance.
• Examine models that are used to efficiently design and produce training solutions that meet specific goals.
• Discuss different models for assessing and evaluating learning and learning programs.

Course outline

• What is this stuff called “knowledge”?
• Tacit versus explicit knowledge
• Knowledge management and what it includes: the knowledge lifecycle
• Regulatory expectations for knowledge management and process understanding
• Moving through the lifecycle:  acquiring, analyzing, storing, disseminating
• Compliance failures and training — identifying the causes
• Training is not the answer to all your problems
• Competency-based training
• A quick look at learning theories: how we learn
• What qualifies a trainer?
• What is an expert?
• Keys to a successful training system – quick review
• Assessment and evaluation — how can you measure success?
• Alignment: Making sure all the pieces fit
• Organizational learning – what it can mean for the business
• Beyond training:  Other ways to disseminate information
• Procedures and checklists
• The connection between training and procedures
• Other tools that support performance
• Evidence of training, learning, and performance
• Evaluating and enhancing YOUR training program

Who should attend

• Compliance officers
• Consultants/service providers
• Engineering and design controls teams
• Executive management
• General/corporate counsel
• Managers
• Manufacturing directors and supervisors
• Medical/technical writers
• Pharmaceutical and cGMP auditors
• QA/QC personnel
• R&D staff
• Regulatory/legislative affairs professionals
• Risk management specialists
• Training personnel
• Validation specialists, scientists, engineers

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