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 involves well-trained personnel. In order to be compliant with the Sarbanes-Oxley (SOx) Act, all US publicly held companies must establish internal controls and procedures for financial reporting to reduce the possibility of corporate fraud.
As such, personnel working in regulated organizations should be skilled in quality and risk management and 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 a full understanding of the fundamental principles of IT Risk and Control in Regulated Environments.
Each participant will have gained knowledge about following topics:
The IT Risk and Control in Regulated Environments Training courses are designed for Business, QA/Compliance, IT personnel and auditors that are new to the regulated environment. It is important, and is also a regulatory requirement, that all individuals working within the Life Sciences 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 in various modules to offer flexibility and to cater for participant needs and circumstances by considering prior learning and level of staff experience. It consists of a curriculum of six courses which comprises multiple modules. The length of each module ranges from 1 to 4 hours and may include exercises, workshops, and formal assessments.
Courses can be given in English or in Dutch. Course material is in English.
The course duration is 7 calendar days (5 full day trainings en 2 half day trainings).
This course can be given at the client’s site or at CTG.
€ 4050 per person
€ 3650 per person on second subscription for the same company
€ 3200 per person on third (or more) subscription for the same company
All prices are VAT excluded; course material, lunch and beverages included.
All 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.* Prices subject to VAT
- Test Plan & Test Lab
This module will provide participants with an understanding of the
process to achieve and maintain a controlled IT Infrastructure and an
overview of the critical IT Infrastructure components.
Maintaining validated systems
Writing SMART Requirements
Writing Effective Test Plans & Reports
Introduction to electronic records and electronic signatures: part 1
Introduction to electronic records and electronic signatures: part 2
Introduction to Life Sciences
This module introduces the concepts and requirements necessary for compliance with relevant GxP requirements and standards for life sciences industries.
Good Documentation in Life Sciences
This module provides the participants with comprehensive understanding of Good documentation Practices, as they pertain to all GxP records and provide real-world examples of good and bad documentation practices. This module can also be used for retraining or a preventive action in response to a documentation deviation.
Overview of Pertinent Regulations & Guidelines
This module provides insight to all pertinent regulations and industry guidelines.
Fundamentals of Risk Management
Introduction to Sarbanes-Oxley (Sox) Compliance
This module introduces the concept of Sarbanes-Oxley (SOx) Compliance and will handle the following topics:
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