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Keynote Presentation From BioMarin: Clarifying Compliance with the FDA Data Integrity Guidance

Fill in the form below to view the opening keynote at Pharma MES USA in 2018  from Eileen Cortes, Director QA, Global Validation at BioMarin as she shares her expertise on Clarifying Compliance with the FDA Data Integrity Guidance.

In her opening keynote, Eileen Cortes, focused on the following topics:

  • Practical application of to ensure compliance
  • Compliant documentation of MES implementation
  • Focus on data justifying software validation
  • Data archiving & electronic audit trail

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