Principles

• While GMPs vary from country to country and for different types of products, they are all based on similar principles: manufacturing processes must be clearly defined and controlled; changes to manufacturing must be comprehensively evaluated prior to changes being made; quality control records must be kept and monitored; and operatives must be fully trained to carry out, monitor and record processes.
  
  

Training

• Training is widely available as in-person, web-based or video and DVD-based courses. Training includes an overview of the Food and Drug Administration and Quality Systems Regulations; management responsibilities; current GMP; audits and corrective action; process changes, equipment inspection and record keeping.
  
  

Federal Regulations

• Code of Federal Regulations Title 21: Chapter 1: Subchapter H -- Medical Devices: Section 820.25 states that manufacturers must establish procedures to identify training needs and that all staff must be adequately trained to perform their duties. It also states that all training must be documented.