This course enables you to handle the validation of IT systems and after the course you know the requirements and strategies for IT validation. This knowledge is essential for you when performing, planning for, and/or approving validation.
This course gives you the overview of the current regulations and best practices for validation of IT systems. You will be familiar with GAMP® 5, EudraLex Vol. 4 Annex 11 and 21 CFR Part 11 with focus on validation, data integrity and compliance. Furthermore, we will discuss the different approaches to validation, and how to plan the validation strategically using risk assessment and the validation master plan.
In addition to the requirements, we will focus on the operational part of validation. You will get tips on how to prepare specifications for the IT system, carry out the validation and ensure traceability between the requirements and the tests.
After the course, you can perform a full validation of IT systems, use your knowledge of the requirements and the V-model as a validation strategy and you will know what it takes to plan and complete an IT validation.
The course is a mix of presentations and workshops, where you will work more in depth with the topics.
The course language is English.
At the course you will meet:
Marjun Jepsen, Validation Engineer at QV-Compliance A/S
Your benefits
The company's benefits
Employees from life science (Pharma and Medical Devices) and suppliers who are involved in the validation of IT systems.
That could for examples be:
The course is a two-day course at Pharmakon with accommodation.
Day 1: 9.00 - 21.00
GAMP® 5 and 21 CFR Part 11/Annex 11
Risk management and assessment of vendors
Validation master plan and validation plan
Specifications
Review of Design and Software System and Dataflow
Day 2: 9.00 - 15.30
Test documentation
Continuity plan and plan for Disaster Recovery
Traceability and maintenance during life cycle
Handling of incidents, changes, and configurations
Planning for decommissioning of the IT system
The course is a mix of presentations with workshops, where you will work more in depth with the topics.
