A risk-based approach to validating computer systems - GAMP 5 training

GAMP 5 training – Overview

This training course on how to validate computer systems covers the essential principles on how to use a risk based approach in Computer Systems Validation (CSV). Whilst referred to as GAMP 5 training by past trainees, the course provides compliance with broad GMP requirements and is designed for professionals seeking training on a practical and cost effective approach.  By using a risk-based approach and an excellent understanding of  various CSV methodologies including those in the Good Automated Manufacturing Practice (GAMP®5) guidance, the waterfall and V models, EU & PIC/S – Annex 11 and the FDA – CFR Part 11.

“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

One day, on your site or at an offsite location.

This GAMP 5 training course can be delivered anywhere in the world, we will ask you to cover reasonable travel costs, with this you could save the costs associated with your staff travelling to a external venue to be trained, so it becomes cost effective if you have several people needing training.

Pricing

Due to significant technology innovation*, we are reducing our pricing to A$300 per person or A$3000 per day plus GST from 2017, with discounts available when more than 10 people attend the same course. This does not include travel costs.

*Smart device and WiFi is needed for all attendees.

Contact us for a quote if you need more that 10 trainees to be trained.

What you will learn

After completing this course, participants will:

  • 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 computerised systems
  • be able to plan scalable validation processes according to patient safety, product quality and data integrity priorities
  • know how to direct computerised 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 computerised systems
  • understand the decision process – selecting off the shelf, customised or totally novel computerised systems
  • understand computerised 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, commonly found in GAMP 5 training courses

Course materials

Participants will receive a workbook with will contain 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

This Computer Systems Validation Training Course is a combination of lecture-style learning and active workshops with participants working in small groups on assigned tasks.

Who should attend?

  • Validation Professionals
  • Quality Assurance personnel
  • Operations or Manufacturing personnel
  • IT personnel

More information

If you would like a quote or would need to ask questions, please contact us.

GAMP® is a registered trademark of ISPE