Course 2 of our Data Integrity Series This course will build on the key messages of course 1 and go beyond the basics.  It will look at some more specialised or particular aspects of this topic which has such a wide-ranging impact.  This course consolidates the knowledge and experience of 11 years of work as 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 course 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 (course 1).   Read more

Course 3 of our Data Integrity Series Data Integrity Course 1, Basics of Data Integrity addressed what everyone needs to know for this essential topic.  Course 2 went beyond the basics focusing on the technical details for subjects such as auditing and computer systems management. In this third course we build on your essential knowledge to understand what the Senior Management should ensure is in place, in use and effective. Read more

Data Integrity: Overview and Documentation Completion, Review and Approval Course 1 of our Data Integrity Series Problems with data integrity continue to lead to vigorous regulatory actions. Such issues can be prevented with a thorough knowledge and understanding of the regulators’ requirements.  This eLearning course is aimed at anyone working in the Pharmaceutical Industry and is designed to provide an overview of what is meant by data integrity, what needs to be considered during documentation completion, review and approval and how to keep your data complete, consistent and accurate throughout the data lifecycle. Data Integrity: Beyond the Basics This course (course 2) will build on the key messages of course 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.   Data Integrity: Management Requirements Data Integrity course 1, Basics of Data Integrity addressed what everyone needs to know for this essential topic.  Course 2 went beyond the basics focusing on the technical details for subjects such as auditing and computer systems management. In this third course we build on your essential knowledge to understand what the Senior Management should ensure is in place, in use and effective. Read more

Free Introduction to our Data Integrity Series   In this FREE introduction to NSF's eLearning courses on Data Integrity, our expert, Rachel Carmichael, takes a high-level look at why Data Integrity matters so much. We explain the structure of our eLearning modules, exploring the expectations from the diverse guidance documents. Read more

Treten Probleme mit der Datenintegrität auf, hat dies nach wie vor einschneidende regulatorische Maßnahmen zur Folge. Durch fundierte Kenntnisse und ein tiefgreifendes Verständnis der Auflagen seitens der Aufsichtsbehörden können Probleme wie diese jedoch nachhaltig unterbunden werden.  Dieser eLearning-Kurs richtet sich an alle Mitarbeiter in der pharmazeutischen Industrie. Er soll einen Überblick darüber geben, was mit Datenintegrität gemeint ist, was bei der Dokumentationserstellung, Dokumentationsprüfung und -genehmigung zu berücksichtigen ist, und wie Sie sicherstellen, dass Ihre Daten während des gesamten Datenlebenszyklus vollständig, konsistent und präzise sind.   PLEASE NOTE: THIS COURSE CONTAINS GERMAN VOICE OVER WITH ENGLISH ANIMATION.   Read more

This 30 minute self-paced learning course provides an overview of the requirements of a deviation investigation and CAPA process. It defines the key features of the system, as well as the lifecycle of the deviation investigation steps: Defining the problem, Conducting a risk assessment, Collecting and analysing data, Conducting root cause analysis, Developing and implementing CAPA’s, Final impact assessment/Deviation closure and Conducting effectiveness checks. Read more