Developing Effective Compliant Documentation and Training System 2018

Topics

• 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

Who should Attend

• Regulatory Documentation Departments
• Training and Development Departments
• Operations Departments
• Human Resources Departments
• Technical Services Departments
• Manufacturing Departments