Computer System Validation

This course is designed for people who need an introduction to computer system validation within a GMP-regulated industry.

The Code of Good Manufacturing Practice for Medicinal Products states;

“It is a requirement of GMP that manufacturers identify what validation work is needed to prove control of the critical aspects of their particular operations. Significant changes to the facilities, the equipment and the processes, which may affect the quality of the product, should be validated. A risk assessment approach should be used to determine the scope and extent of validation.”

Course Duration & Location

3-5 days, on your site or at one of our training centers.

CiPharma’s training courses can be delivered anywhere in the world. If your site is not in a city we have an office in then we ask you to cover the travel costs from our nearest office. You’ll save the costs associated with your staff travelling to be trained, so it becomes cost effective if you have several people needing training.

What you will learn

  • Understand the importance of validation and why and how the information is collected and used
  • Have an understanding of the V model and how it is used
  • Know what Validation Master Plans (VMP), User Requirements Specifications, Functional Specifications and Design Specifications are and how and when to use them.
  • Know what Design review / Design Qualification are and when they should be used in a project
  • Know the steps involved in Installation Qualification, Operational Qualification and Performance Qualification
  • Know what a Validation Summary Report is and when it should be used
  • Be able to perform basic validation testing
  • Have a rudimentary understanding of risk based validation
  • Understand how to adopt sensible validation practices
  • Course materials

    Participants will receive a copy of the presentation(s), relevant notes and workshop materials.

    A certificate of completion will be issued to participants who successfully complete the assessment.

    Assessment

    A written assessment is conducted at the end of the course.

    Course Format

    The course is a combination of lecture-style learning and active workshops with participants working in small groups on assigned tasks.

    Who should attend?

  • Quality Control personnel
  • Operations or Manufacturing personnel
  • Engineering personnel