GAMP 5 Training Course - A Risk-Based Approach to Compliant GxP Computerized Systems (GAMP5)

Okay you have heard about GAMP 5 and want to know more?

This one day course covers the essential principles contained in GAMP 5 for 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”

Learning Objectives and Course Description

This validation course covers the following topics;

completely understand the key concepts of GAMP 5
have a through understanding of the V model and its application to GxP computer systems
use the GAMP 5 Risk Based approach to reduce validation costs
writing and structuring User Requirements Specification, Functional Specification and Design Specification using the Risk-Based approach
design review / Design Qualification
how the validation ‘V’ model applies to GxP computerised systems
scalable validation processes according to patient safety, product quality and data integrity priorities
how to direct computerised validation projects
the major life cycle phases of computerized systems, from concept to retirement
software categorization and the Validation efforts required for various computerised systems
the decision process – selecting off the shelf, customised or totally novel computerised systems
computerised system validation from a regulator’s perspective
how to do code reviews
Electronic Records Electronic Signatures (ERES) and CFR Part 11 compliance
understanding key validation deliverables
leverage supplier involvement to reduce duplication

During this day GAMP 5 course participants will have an excellent knowledge and appreciation of GAMP 5, this is a revolutionary document.

Benefits include

Trainees will:

Learn from instructors who are actively involved in various validation studies across the life sciences industries
Understand how to adopt sensible validation practices
The trainer is an ISPE Australian affiliate board member
Receive a complete training kit, trainer’s notes and a certificate of completion for participants assessed.

We have many years experience consulting on GAMP 4 and if you are interested on What's new in GAMP 5, read on.