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Comprehensive regulatory requirements including the regulatory framework, pre- and post-market requirements, and instruction on the way Australia is utilizing MDSAP. Read More

Comprehensive regulatory requirements including the regulatory framework, pre- and post-market requirements, and instruction on the way Brazil is utilizing MDSAP. Read More

Comprehensive regulatory requirements including the regulatory framework, pre- and post-market requirements, and instruction on the way Canada is utilizing MDSAP. Read More

This course provides a comprehensive overview of China's medical device regulatory framework, including both pre-market and post-market requirements. China’s medical device regulation program has evolved rapidly over the past two decades. This two-hour overview covers the changes and key aspects of the regulations as they pertain to both domestic and overseas manufacturers. 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 provides 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

Module 2 of our Data Integrity Series This course (module 2) will build on the key messages of module 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 module 2 of our Data Integrity series of courses.  We would suggest that prior to this course you take module 1, Data Integrity: Overview and Documentation Completion, Review and Approval course.   Read More

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