Module 2 of our Data Integrity Series
This course (module 2) will build on the key messages of module 1 and go beyond the basics. It will look at some more specialised or particular aspects of this topic which has such wide ranging impact. This course consolidates knowledge and experience of 11 years work from an ex MHRA Inspector. Management and the Quality Unit need to have a deeper understanding of Data Integrity to give them the confidence to get involved and this module is designed to highlight the known weaknesses in company systems.
This course is module 2 of our Data Integrity series of courses. We would suggest that prior to this course you take module 1, Data Integrity: Overview and Documentation Completion, Review and Approval course.
The module is split into 4 parts
- Part 1 explores self-inspection and internal auditing – all auditors should be trained in the specific considerations of Data Integrity and this part identifies the many aspects that can be considered. Suitable for experienced and new auditors alike as well as department management subject to such audits.
- Part 2 is a short module highlighting the benefits of GEMBA walks from a Data Integrity point of view and how this approach differs from self-inspection and can contribute to increasing overall understanding and relationship building.
- Part 3 considers some of the different types of deficiencies experienced in different parts of the operation – highlighting previously known issues and how they may be identified
- Part 4 focuses on Computers Systems Considerations – what should be in place for electronic systems throughout the data lifecycle , identifying aspects to consider, to build the confidence of Operational Management, the Quality Team – for the non IT professional
By completing/passing this course, you will attain the certificate Medical Device Certificate
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