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

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

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. Read More

This session is ideal for engineering technicians as well as contract and technical support staff who need to be aware of how their actions may create or contribute to GMP non-compliances, which may affect product quality. Exercises and case studies help you recognise how much interaction you have with GMP-compliant processes/systems, how to mitigate risks associated with each interaction with validated/qualified systems and your key role in maintaining compliant processes within the bigger team. A certificate will be issued upon successful completion of a short end of session assessment.  Read More

This training course covers the GxP Inspection Management Lifecycle.  It is suitable for staff wanting to understand more about GCP, PV, GMP and GDP regulatory inspections from planning, conduct and responding to inspection findings.  Read More

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