Course Description

21 CFR Part 11 Electronic Records and Electronic Signatures



The main objectives of this course are to give attendees a grounding in the principles of and latest requirements for Electronic Records and Electronic Signatures (ERES). 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 both computer hardware and software systems used in Manufacturing, QA, Regulatory and the Control of Processes. The course also covers the latest FDA Guidance on Electronic Records and Signatures. Quality Risk Management as applied to Electronic Records and Signatures and validation of systems that use ERES are also addressed.

Training ProviderSQT Training Ltd
Course LocationCastletroy, Limerick
Course CategoryInformation Technology
Course Duration1 day
Course Time9am-3pm
Phone061-339040
For information about SQT Training Ltd, please visit our Training Provider page on Corporatetraining.ie by clicking here.

Course Provider

SQT Training Ltd



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

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