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

Course code: GAMP5

Overview

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

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

PharmOut'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.

Pricing

Indicative pricing is A$500 per person or A$4500 per day, with discounts available when more than 10 people attend the same course.

What you will learn

After completing this course, participants will:

• 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 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

 

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

More information

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