Quality Intelligence: Using Annex 11 as a Roadmap for Implementing Agile Software Solutions

Presenter: Peter Baker, President, Live Oak Quality Assurance LLC

The new EU Annex 11 and associated PIC/s guidance represent a major shift in regulatory expectations for data integrity. This shift was necessary due to the exponential growth of GXP data that needs to be managed from generation to retirement. Previous guidance was ill-equipped on how to deal with the vast amount of GXP data now generated on a daily basis. In this 45 minute webinar, we discuss new additions to the regulation that outline expectations for flexible and risk-based strategies for GXP data management, including the use of non-traditional software (e.g., Power BI, etc.) to assist with governance of large data sets.

Join us for this interactive webinar where you will receive expert instruction from an ex-FDA software, data integrity, and data compliance expert!