Introduction to Computerised System Validation

The Life Sciences industry is one of the most regulated industries in the world, and is subject to regulation by different government agencies. Pharmaceutical, biotechnology, clinical research, medical device and healthcare companies are required to meet relevant GxP requirements for their business operations which involve well-trained personnel.

Personnel working in regulated organizations should be skilled in computerized system validation activities to ensure these organizations are in compliance with pertinent regulatory requirements. CTG can provide training to your employees to ensure they are appropriately trained and have adequate skills and experience to perform their assigned duties.

Upcoming

09-05-2019


Introduction to Computerised System Validation

Course Objectives

The goal of this course is to provide an understanding of computerized system validation.

Each participant will have gained knowledge about following topics:

  • History and purpose of CSV in regulated environments
  • GAMP 5 concepts to CSV
  • Produce validation documentation required for the implementation of computerized systems
  • Elements required for the maintenance of validated systems
  • Create key validation documents needed for the use and maintenance of the system
  • Perform remedial activities
  • Regression testing and retrofitting of functionalities
  • Change control process
  • User requirements specifications and the role it plays in CSV
  • Understand why URS plays a major role in achieving business and regulatory requirements
  • How requirements are created and approved
  • Stakeholders involved and their responsibilities
  • Required elements and qualities of a URS
  • Test documentation and their role to CSV
  • How testing is created and approved, including the responsibilities of those performing the activities
  • Required elements and qualities of test documentation

Typical Audience

The Introduction to Computerized System Validation course is designed for Business, QA and IT personnel that are new to the regulated environment. It is important, and is also a regulatory requirement, that all individuals working within the life science industry receive GxP training and are capable of performing their assigned duties.


Course Prerequisites

A basic knowledge of English is required.


Course Delivery

The training is given in a classroom format and is structured to offer flexibility and to cater for participant needs and circumstances by considering prior learning and level of staff experience. Courses can be given in English or in Dutch. Course material is in English.


Course Venue

The course duration is 2 days.

This course can be given at the client’s site or at CTG.

Course Administration

Pricing

€ 1400 per person
€ 1300 per person on second subscription for the same company
€ 1150 per person on third (or more) subscription for the same company

All prices are VAT excluded; course material, lunch and beverages included.

Cancellation

  • By Participant: If a subscribed course participant is replaced by another participant or if the public course is postponed to a later date, no cancellation costs apply. A participant or a group that fails to attend, or that cancels a course without at least 15 working days written notice prior to the course start, is liable for the full subscription cost.
  • By CTG: CTG reserves the right to cancel a course at any time.

Course Logistics

These classroom courses start promptly at 9 am and are scheduled until 5 pm. All courses are organised at the CTG premises in Diegem (Belgium).
All courses can be given at the client site and are available for groups as well. Please contact us if you wish further information.
The standard language of each course is English.

Course Outlines



CSV Fundamentals

  • This module will provide participants with an understanding of the computerized system validation process following the GAMP V-model.

Maintaining validated systems

  • This module is directed towards understanding of operational validation activities required to maintain the validated state of production systems.

Writing SMART Requirements

  • This module is directed towards understanding of computer system requirements applicable to GxP environments, reflection of regulatory expectations and best practices in writing requirements.

Writing Effective Test Plans & Reports

  • This module is directed towards understanding of the testing phase of computer system validation and will include reflection of regulatory expectations for testing and best practices in writing test documentation.

Meet our trainers

CTG's trainers are experts in their domain and bring the course content based on their experience. Meet some of our trainers below.
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Contact

Europe

CTG Belgium NV

Woluwelaan 140A
1831 DIEGEM
Belgium
phone: +32 2 720 51 70
fax: +32 2 725 09 20

North-America

Buffalo, New York

800 Delaware Ave

Buffalo, NY 14209-2094

phone: +1 716 882 8000

fax: +1 716 887 7464