Data Integrity and Data Governance in GMP – Latest Regulatory Trends
👥 Ulrich Köllisch and James Francum will provide you with the newest regulatory changes and reflect on inspection trends in 2023 in the area of Data Integrity and Data Governance.
🔍 Together, we’ll peer into the near future, discussing our expectations for the coming year.
This webinar provides an overview about inspection trends and latest industry guidelines in 2023 (and beyond).
We will check FDA’s inspection database and uncover some recurring inspection topics in 483s and Warning Letters such as Vigilant Monitoring (using data), completeness of manufacturing data and issues with third parties.We will investigate the hot topics for the future guiding us away from Data Integrity as a “compliance activity” towards data as the enabler for knowledge management and Quality Intelligence.
We will check FDA’s inspection database and uncover some recurring inspection topics in 483s and Warning Letters such as Vigilant Monitoring (using data), completeness of manufacturing data and issues with third parties.We will investigate the hot topics for the future guiding us away from Data Integrity as a “compliance activity” towards data as the enabler for knowledge management and Quality Intelligence.
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