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Data Integrity: Beyond the Basics

NSF International, Pharmaceutical Services
Course summary
2 hours
145 GBP excl. VAT
English
Online courses
Next available date: Enquire for more information - Online courses

Course description

Data Integrity: Beyond the Basics

This course (module 2) will build on the key messages of module 1 and gobeyond 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 the free Data Integrity Introduction course, followed by the Data Integrity: Overview and Documentation Completion, Review and Approval course (module 1).  

Outcome / Qualification etc.

By completing/passing this course, you will attain the certificateNSF Certificate of Attendance

Training Course Content

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

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About provider

NSF International provides a comprehensive range of independent, third-party pharmaceutical and biotech support services covering consulting, training, auditing and regulatory guidance for the pharmaceutical industry. These services are delivered by some of the most knowledgeable experts in their fields. Our unique...


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Contact info

NSF International, Pharmaceutical Services

The Georgian House, 22/24 West End
Kirkbymoorside
YO62 6AF York


Reviews

Average rating 5

Based on 2 reviews

Anonymous
(5)
Another insightful session of data integrity and good practice.
Anonymous
(5)
Really good second course. Easy to follow through with clear explanations of principles and some great examples
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