GAMP 5

This course covers the essential principles contained in GAMP 5: A Risk Based Approach to Compliant GxP Computer Systems Validation. This GAMP course is designed for professionals seeking training in the requirements of GAMP 5, for example;

  • Quality Assurance personnel
  • IT personnel
  • Engineering personnel

“There are major business benefits in having a defined process that delivers systems that are fit for intended use, on time, and within budget. Systems that are well defined and specified are easier to support and maintain, resulting in less downtime and lower maintenance costs…”

ISPE, GAMP 5, A Risk-Based Approach to Compliant GxP Computerized Systems”

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

  • Completely understand the key concepts of GAMP 5
  • Have a through understanding of the V model and its application to GxP computer systems
  • Be able use the GAMP 5 Risk Based approach to reduce validation costs
  • Know how to write and structure a User Requirements Specification, Functional Specification and Design Specification using the Risk-Based approach
  • Know what a design review / qualification is and when it is used
  • Know how the validation ‘V’ model applies to GxP computerized systems
  • Be able to plan scalable validation processes according to patient safety, product quality and data integrity priorities
  • Know how to direct computerized validation projects
  • Understand the major life cycle phases of computerized systems, from concept to retirement
  • Understand software categorization and the Validation efforts required for various computerized systems
  • Understand the decision process – selecting off the shelf, customized or totally novel computerized systems
  • Understand computerized system validation from a regulator’s perspective
  • Know how to do code reviews
  • Understand Electronic Records Electronic Signatures (ERES) and CFR Part 11 compliance
  • Be able to identify key validation deliverables
  • Know how to leverage supplier involvement to reduce duplication

  • 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 Assurance personnel
  • Operations or Manufacturing personnel
  • IT personnel