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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.
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.
Participants who have
attended three courses/ conferences receive upon request in addition to
the individual certificates the certificate "Computer Validation Manager,"
which identifies the participant as a qualified expert in the field of
computer validation.
- GMP Compliance for Computer Validation
- User Requirement Specifications on Computer
Validation
- Risk Assessment and Change Control in Computer
Validation
- 21 CFR Part 11 Compliance. FDA Requirements on
and Implementation of Electronic Records / Electronic Signatures
- How to Qualify IT Networks
- FDA/GMP Requirements on IT Infrastructure
- Validating Computerised Analytical Equipment
and Systems
- Writing User Requirement Specifications to Meet
FDA Guidelines
- Exploiting the Benefits of Electronic
Signatures
- SAP R/3 Validation and Part 11 Implementation
- Validation of Process Control Systems: GMP/FDA
Requirements on and GAMP Approach to the Validation of PLCs and DCSs
- Records, Risks and Regulations
The following link leads you to upcoming
events recognised for the
Certified
Computer Validation Manager (ECA).
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