Developing Effective Compliant Documentation and Training System 2018 covers topics such as:
- The Training and Development Process
- The ADDIE Process explained
- Why is having a defined training development process is important?
- The activities performed during each step of the ADDIE process
- The interrelated aspects of each training development phase
- The inputs and outputs of each step of the ADDIE process
- Achieving Excellence through Training & Documentation
- How training, documentation, and management action impact operational excellence - elements of compliance excellence
- The relationship between human behavior and organizational performance
- Making it all real - let`s look at a case study
- The cost of human capital - what it costs and what it can yield
- Implementing the model in your organization
- Regulatory Documentation - The Foundation
- What is the value-add?
- The true purpose and function of regulatory documentation
- The documentation hierarchy
- The pitfalls associated with writing regulated documentation
- Gathering the technical information, you need
- Documentation formats
- Documentation writing tips
- Using Subject Matter Experts
- Managing technical document reviews
- Training and Development Basics
- Our senses and how we learn
- Education, training, and memory
- The elements of training - duties, tasks, and steps
- The Job - the basis of all technical training where we work
- Performance objectives - what are they and why are they important
- Selecting tasks for training
- Testing - how it works and why it is important
- Training & Development - the Implementation Method
- Explain the types of training applications that are appropriate in given circumstances
- The training delivery process
- Discuss the training pitfalls and misapplications of training and their impact upon regulatory compliance
- Training beyond GMPs
- Explain how training should be managed in the modern regulated industry
- Discuss the dangers in relying upon "Read and Understand"
- Conducting a documentation and training analysis
- How regulatory documentation and training are linked
- Elements of a regulatory documentation and training program
- Areas of the organization/process that must be examined and analyzed
- Regulatory compliance documentation hierarchies
- Training task characteristics that impact training delivery
- Conducting the analysis - using subject matter experts
- Use of the Analysis Tool to capture the required information
- Putting it all Together
- Training trainers
- Building an effective training function
- Executing effective training
Developing Effective Compliant Documentation and Training System 2018 brings together:
- Regulatory Documentation Departments
- Training and Development Departments
- Operations Departments
- Human Resources Departments
- Technical Services Departments
- Manufacturing Departments