Kurser
Konsulentydelser
Forskning
‹ Tilbage
With this course you will be ready to handle the validation of IT systems and after the course you know the requirements and strategies for IT validation. This is essential regardless if you are performing, planning for, or approving the validation.
The course will give you an overview of the current regulations and best practice for validation of IT systems. You will come through 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 approached to validation, and how to strategically plan the validation using risk assessment and the validation master plan.
In addition to the legislation, we focus on the more operational part of validation. You will receive 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 are ready to perform a full validation of IT systems, as you have insight into the legislation and the V-model as a validation strategy, and know what it takes to plan and complete an IT validation.
The course is a mix of presentations with workshops, where you will work more in depth with one or more topics.
The course is held in English and the teacher is:
Validation Engineer, Marjun Jepsen, QV-Compliance A/S
Employees from Pharma, Medical devices and suppliers who are involved in the validation of IT systems.
That could be:
The course is a two-day course at Pharmakon with accommodation.
Day 1 p.m. 9.00 - 21.00
Day 2 p.m. 9.00 - 15.30
Topics at the course are:
• GAMP® 5 & 21 CFR Part11 /Annex 11
• Risk management and assessment of vendors
• Validation master plan and validation plan
• Specifications
o User Specification Requirement
o Functional Specification
o Design Specification
• Review of Design and Software
• System and Dataflow
• 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 one or more topics.
