Validation of IT systems

Understand how to use the current standards for IT validation

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

Kursusfakta
Niveau
Specialiserede
Format
2 dage
Vurdering
4,7 ud af 5
Pris i år
12.900 kr. ekskl. moms, overnatning inkluderet
Tilmeld dig her
Hillerød
30. aug.
31. aug.
2021
Hillerød
29. aug.
30. aug.
2022

Dine fordele ved at vælge dette kursus

Dit udbytte

Your benefits

  • you know the current requirements for IT validation
  • you can plan and complete a validation of IT systems
  • you can demonstrate internally as well as externally that your IT systems are in compliance.

Din virksomheds udbytte

The company's benefits

  • your employee knows the process for IT validation and can participate actively
  • your employee takes the responsibility for the complete validation of IT systems
  • your employee ensures that your IT systems are in compliance.
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Målgruppe

Employees from life science (Pharma and Medical Devices) and suppliers who are involved in the validation of IT systems.

 

That could for examples be:

  • Technical employees performing the validation
  • Project managers planning the validation
  • Suppliers who design and program IT systems
  • QA’s approving the protocols, test plans and reports.

Kursusagenda

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

  • User Specification Requirement
  • Functional Specification
  • Design Specification

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.

Tilmeld dig her
Hillerød
30. aug.
31. aug.
2021
Hillerød
29. aug.
30. aug.
2022