To define and explain key elements for efficient management of the training function required to establish a strong learning infrastructure. This makes it possible to meet GMP requirements and allows strategic learning initiatives to meet business needs in today’s industry.

This course will cover the following topics:

1. Management of the training function in today’s regulated environment:

• Clarify regulation’s expectations
• Clarify business needs in today’s market of manufacturing drug products
• Describe the process of managing training
• Describe the training needs analysis process

2. Develop efficient training programs:

• Explain the process of evaluating training requirements and developing efficient training programs
• Identify key requirements for trainer’s qualification
• Define basic concepts of training design
• Identify various methods to measure training effectiveness

3. Training and performance management:

• Identify key factors of performance at work
• Explain how performance is developed and the conditions of success
• Identify key considerations when advising on performance issues
• Explain how humans make mistakes and how to prevent them

4. Training as a strategic partner:

• Describe the process of performing a strategic need analysis and setting the objectives of a training department
• Training as a support to culture, changes, and continuous improvement