Computerised systems that illustrate or control quality-relevant processes are in widespread use throughout the pharmaceutical industry. Not only are they subject to the requirements of the various collections of pharmaceutical regulations for the validation of these systems, but since 1997 the US authority FDA lays down requirements concerning electronic records / electronic signatures in 21 CFR Part 11. Also, since 1994 the GAMP® Guide provides a worldwide acknowledged industry guideline for the validation of computerised systems - and is available as version 5 since 2008. The basic guideline was and still is constantly expanded by various Good Practice Guides concerning specific aspects.
In the GMP Certification Programme "Computer Validation Manager" participants obtain a comprehensive knowledge of the basic principles for the validation of computerised systems, the requirements of Part 11 and specific aspects of the validation of computerised systems.
To receive the certificate, the applicant must attend three courses and/or conferences. After attending the third course, the applicant obtains the certificate "ECA Certified Computer Validation Manager". Please find some potential training courses below
For questions relative to the ECA Certified Computer Validation Manager, please contact email@example.com.