Scope
This course is designed to provide guidance on how data should be controlled and managed from initial generation and recording, through processing, use, retention, archiving and retrieval.
Data Integrity is assuming greater importance in cGMP, with both the FDA and European Regulatory Agencies placing a high degree of focus on the subject. This course will help to interpret expectations, and guide you in defining and implementing an appropriate data governance process in relation to manual (paper) and electronic data.
Suitability
This course is suitable for people with the responsibility of ensuring or assessing the GMP compliance to requirements and expectations relating to the control and management of data within the pharmaceutical industry.
The content is applicable to users within, and managers and auditors of areas that generate, process, and use or store GMP data.
By the end of this course you will:
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Understand the importance of data integrity
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Appreciate how data integrity could impact your facility
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Know how to integrate data governance into your quality systems
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Recognise the challenges and therefore be able to identify areas where falsification could occur
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Understand the difference between mistakes and falsification or fraud
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Be able to identify the data lifecycle elements for both manual (paper) and electronic data
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Understand the potential risks and weaknesses associated with the lack of control of data
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Know how to incorporate the aspects of data integrity into the design and qualification of new equipment
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Be able to check for compliance against data integrity expectations
