Only 3 Spaces Remaining on GAMP 5 Computer Software Validation Training Course - Dublin

17 February, 2012

The main objectives of this course is to give attendees the ability to apply the GAMP® 5 approach to categorise software and hardware for a networked and configured computerised system.
THis course defines the appropriate engineering and life cycle activities and describes the suite of documentation required to maintain the system in a validated state.
The course provides an overview of the FDA and European requirements with practical exercises covering the implementation of those requirements. It covers the application of these requirements to the validation of both computer hardware and software systems used in Manufacturing, QA, Regulatory and the Control of Processes.
The GAMP 5 Computer Software Validation Training Course also covers the latest FDA Requirements and Guidance on Electronic Records and Signatures (21 CFR Part 11) and Quality Risk Management as applied to Computer Systems Validation. It gives guidance on leverage and management of suppliers and outsourcing to reduce the validation effort. The validation of Excel spreadsheets and other small bespoke applications is also covered.

Upon completion you will understand and be able to interpret the key requirements for your organisation, ensuring computerised systems within your organisation are fit for purpose and meet current regulatory requirements.

There are a limited number of spaces remaining on this course on February 23rd and 24th in Dublin.

Further Course Details are here:

Contact Seamus: or 021 - 240 62 50


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