Course Description

Software Validation (Virtual)

SQT Training Ltd



The main objectives of this course are to give attendees a grounding in the principles of Software Validation, Computer Systems Validation and the latest requirements for Electronic Records and Electronic Signatures. The course provides an overview of the FDA and European requirements with practical exercises covering the implementation of those requirements. The course 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 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 Software Validation and Computer Systems Validation.

Participants achieve the following learning outcomes from the programme;

  • Apply the principles of Software Validation and Computer Systems Validation
  • Implement the Validation Life Cycle approach to software and computer systems
  • Apply Quality Risk Management techniques
  • Generate key validation documents such as URS, FDS, VMP, IQ, OQ and PQ
  • Apply the requirements of 21 CFR part 11 in relation to Electronic Signatures & Records

College Name SQT Training Ltd
Course Category Life Sciences, Science & the Built Environment
Course Type Online Learning
Course Qualification Level 1 Certificate
Course Location Limerick, Ireland
Course Start Date 4th November 2020
Course End Date 11th November 2020
Course Fee 795
Course Duration Two days
Course Times (4 x 1.5 hrs morning and afternoon sessions)
For information about SQT Training Ltd, please visit our college page on www.nightcourses.com by clicking here.

Course Provider

SQT Training Ltd



(061) 339041
Callan Centre Castletroy, National Technology Park, Various Locations around Dublin, Dublin, Republic of Ireland

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SQT Training Ltd
Callan Centre Castletroy, National Technology Park, Various Locations around Dublin, Dublin, Republic of Ireland