GxP data integrity: What you don't know may make you non-compliant

Data Integrity for GxP Monitoring systems
Life Science

Maintaining data integrity is about more than regulatory compliance. In life science applications, data often represents a significant investment in research, development, samples or donated tissue. In life science, data can also represent the hope of patients for a novel therapy or drug. All GxP processes require trustworthy systems to ensure patient safety.

In this webinar you will learn how to maintain data integrity in GxP-regulated environmental monitoring applications. Along with best practices, we provide an up-to-date overview of the current regulatory expectations. Attend the live session to take part in the question period. Vaisala's regulatory expert will answer your questions on data management best practices for GxP-compliant monitoring.

Key learning objectives:

 

  •     Overview of guidance and publications
  •     Sample Warning Letters on data management failures
  •     How to detect and evaluate risks to data integrity
  •     Common pitfalls in data management
  •     Review of data integrity best practices

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Paul Daniel, Vaisala

Senior GxP Regulatory Compliance Expert

Paul Daniel has worked in the GMP-regulated industries for over 20 years helping manufacturers apply good manufacturing practices in a wide range of qualification projects. His specialties include mapping, monitoring, and computerized systems. At Vaisala, Paul oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system. He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications. Paul is a graduate of University of California, Berkeley, with a bachelor's degree in biology.