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Fundamentals of GXP Data Integrity/Governance
The Stage 1 workshop is focused on developing a solid understanding of the foundations of GXP data governance and data integrity assurance outlined in the newly published EU Annex 11 and associated PIC/s Guide. In this two-day workshop we discuss current regulatory expectations and guidance, including the basics of DI: the ALCOA principles, with the goal of developing a comprehensive understanding of how to operate efficiently within a GXP regulated environment. We discuss risk-based approaches to ensure regulatory compliance; referencing current regulations, regulatory actions, and harmonized guidance.
Fundamentals of GXP Data Integrity/Governance
The Stage 1 workshop is focused on developing a solid understanding of the foundations of GXP data governance and data integrity assurance outlined in the newly published EU Annex 11 and associated PIC/s Guide. In this two-day workshop we discuss current regulatory expectations and guidance, including the basics of DI: the ALCOA principles, with the goal of developing a comprehensive understanding of how to operate efficiently within a GXP regulated environment. We discuss risk-based approaches to ensure regulatory compliance; referencing current regulations, regulatory actions, and harmonized guidance.