BRIEF INFORMATION

This three-day intensive training course provides professional staff development in pharmaceutical companies taking into account industry specificity and helps to implement Quality Management System (QMS)

 TARGET AUDIENCE

  • Heads of production, quality control and quality assurance departments of medical products manufacturers and medical equipment manufacturers
  • Team members responsible for development and implementation of QMS based on ISO 13485
  • Future internal auditors of QMS

 THE PROGRAM OF THE TRAINING COURSE

  • Introduction to QMS
  • ISO 13485 requirements
  • QMS
  • Management’s responsibility
  • Resource management
  • Sales of products
  • Measurement, analysis and improvement
  • Risk Management
  • Documentation requirements
  • Compatibility with GMP and other QMS Standards
  • 13 assignments, testing