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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.
For questions relative to the ECA Certified Computer Validation Manager,
please contact
heimes@gmp-compliance.org.
To receive the certificate, the applicant must attend three out of the
following courses / conferences. After attending the third course, the
applicant obtains the certificate "ECA Certified Computer Validation
Manager".
- IT System and Data Security: GMP requirements and technical measures
- Computer Validation - the GAMP®5 Approach
- Computer Systems Validation Masterclass
- Computer Validation: Introduction to Risk Management
- Computer Validation: Maintaining the Validated State
To get to the calendar with all courses and conferences currently
offered for this programme - including a link to the contents and a
booking form - please go here.
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