Solution Architect, Regulatory Compliance
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.
The “Introduction to Life Sciences Training” introduces the concepts and requirements necessary for compliance with relevant GxP requirements and standards for Life Sciences industries. It also 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. Finally the course also gives insight to all pertinent regulations and industry guidelines.
CTG can provide training to your employees to ensure they are appropriately trained and have adequate skills, knowledge and awareness to work in the Life Sciences industry.
The goal of this course is to create awareness about the fundamental principles of compliance with pertinent regulations and industry guidelines in the Life Sciences industry.
Each participant will have gained knowledge about following topics:
The “Introduction to Life Sciences Training” 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 Sciences industry receive GxP related 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 1 day.
This course can be given at the client’s site or at CTG.
€ 750 per person
€ 695 per person on second subscription for the same company
€ 600 per person on third (or more) subscription for the same company
All prices are VAT excluded; course material, lunch and beverages included.
This classroom course starts promptly at 9 am and is scheduled until 5 pm. All courses are organised at the CTG premises in Diegem (Belgium).
All courses can be given at the client’s site and are available for groups as well. Please contact us if you wish further information.
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.
CTG Belgium NV
phone: +32 2 720 51 70
fax: +32 2 725 09 20
Buffalo, New York
800 Delaware Ave
Buffalo, NY 14209-2094
phone: +1 716 882 8000
fax: +1 716 887 7464