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.
The goal of this course is to provide an understanding of computerized system validation.
Each participant will have gained knowledge about following topics:
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.
A basic knowledge of English is required.
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.
The course duration is 2 days.
This course can be given at the client’s site or at CTG.
€ 1440 per person
€ 1330 per person on second subscription for the same company
€ 1170 per person on third (or more) subscription for the same company
All prices are VAT excluded; course material, lunch and beverages included.
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.
Maintaining validated systems
Writing SMART Requirements
Writing Effective Test Plans & Reports
CTG Belgium NV
phone: +32 2 720 51 70
fax: +32 2 725 09 20
800 Delaware Ave
Buffalo, NY 14209-2094
phone: +1 716 882 8000
fax: +1 716 887 7464