The purpose of this course is to provide an introduction to Pharmacovigilance and why it is required to monitor the detection, assessment and prevention of adverse events, adverse reactions and side effects of medicinal products post marketing. Read More

This course of four chapters will give you a sound basis of the regulatory requirements expected of a good pharmaceutical cleaning process, how to calculate limits and their justification. The pros and cons of various cleaning methods and how to approach them. Finally, how to plan and approach a validation exercise with specific cleaning acceptance criteria. Read More

The purpose of this course is to provide an overview of current good CSV practice along with some practical advice about how to achieve good outcomes in a cost-effective and resource-efficient way. 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 modules 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

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 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 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