Developing Effective Compliant Documentation and Training System


Developing Effective Compliant Documentation and Training System 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 brings together:

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

Future Events

Developing Effective Compliant Documentation and Training System 2020


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