EBR as the GPS for pharma manufacturing – improving quality by going digital.

This presentation delves into crucial aspects of pharmaceutical and manufacturing compliance, including GMP/FDA-compliant batch record design and review, cGMP compliance monitoring at external sites, deviations/investigation assessment, the role of MES in Electronic Batch Records (EBR), and the comparative value of full EBR reviews versus reviews by exception.

Jignasa Oza

Head of Quality Assurance at Sanofi