Solution Architect, Regulatory Compliance
“Tel me and I forget. Teach me and I remember. Involve me and I learn.” - Benjamin Franklin
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.
Some of these GxP requirements are applicable to GxP critical records and signatures. When those critical records and signatures are kept and managed electronically, specific regulations apply. For products sold in the US market 21 CFR Part 11 applies. For products sold in the European market, the electronic records and signatures have to comply with EudraLex Volume 4 Annex 11.
CTG can provide training to your employees to ensure they are appropriately trained and have adequate skills and experience to work with and manage electronic records and electronic signatures in an efficient and compliant manner.
The goal of this course is to provide understanding of common quality practices for electronic records and electronic signatures (ERES) applicable to GxP environments. The training also provides a reflection of regulatory expectations for computer systems that use electronic records or signatures. This training discusses further on the concepts and requirements of ERES and provides details on the remediation of ERES compliance gaps.
Each participant will have gained knowledge about:
The “Introduction to Electronic Records and Electronic Signatures Training” course is designed for Business, QA and IT personnel that are new to electronic records and signatures. 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 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.
€ 770 per person for one day
€ 710 per person on second subscription for the same company
€ 610 per person on third (or more) subscription for the same company
All prices are VAT excluded; course material, lunch and beverages included.
This classroom cours begins 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.* Prices subject to VAT
Introduction to electronic records and electronic signatures: part 1
Introduction to electronic records and electronic signatures: part 2
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