Our fully interactive Software Validation training course provides attendees with the knowledge and skills they need to comply with European, US and Worldwide software validation requirements. The course is fully tutor-led and focuses on the practical implementation of software validation requirements. The course provides attendees with a well-thought-out approach and real-world implementation methodologies, to help achieve compliance and assure consistency of performance of computerised systems. The course addresses the use of software and computerised systems in QMS, production, testing and distribution. Risk Management of software and computerised systems, and scaling of validation effort in proportion to risk are covered in detail. The course also covers the latest FDA Requirements and Guidance on Electronic Records and Signatures (21 CFR Part 11) and Data Integrity. The course involves practical group exercises which take the learner through the entire validation cycle with comprehensive feedback from the course tutor throughout.
For abbreviations used in this document, see end of document.Collapse
(includes course documentation).
With the transition of many medical device companies to ISO 13485:2016 “Medical Devices – Quality Management Systems – Requirements for regulatory purpose...
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