eCTD Submissions of IND/NDA to the US FDA, EU and Canada

It will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD. 

Good Laboratory Practices (GLPs) Comparing and Contrasting GMP

Non-clinical laboratory studies in which tests article are studied in test system under laboratory conditions to determine their safety.

FDA Trends for Computer System Validation (CSV) Compliance and Enforcement

The intent was to avoid creating a huge regulatory compliance cost to industry that was initially preventing companies from embracing the technology.