Webinars

On-demand webinar

Unlocking data integrity: Proven strategies for GxP compliance and inspection readiness

Navigate GxP compliance with confidence

Data integrity is essential for GxP-regulated companies to ensure regulatory compliance, product quality and patient safety. It forms the foundation of trustworthy decision-making and underpins every aspect of the product lifecycle, from development to distribution. Despite being a major focus of regulators for over a decade, and the publication of several guidance documents on the topic to clarify requirements and expectations, inspections still reveal challenges that companies face in maintaining accurate, complete and consistent records. These challenges not only pose risks to compliance but can also lead to costly delays, product recalls, or even harm to patients.

Why are companies still receiving warning letters on data integrity? 

This ongoing issue highlights the critical need for a robust data integrity framework with advanced technologies supported by comprehensive governance.

Join us for an informative on-demand webinar where you will learn:

  • A common-sense interpretation of data integrity regulations
  • The required elements of a comprehensive and robust data integrity framework
  • The importance of data integrity in both non-regulated and regulated environments
  • How real-world examples can help you implement practical compliance strategies tailored to your unique business and regulatory needs

Don’t miss this opportunity to gain valuable insights, learn from others’ experiences, and discover effective approaches for ensuring data integrity.

Watch it now below!

Meet our speakers

Kurt

Kurt In Albon

Quality Expert in Computerized Systems Validation and GxP Compliance

Kurt brings over 30 years of experience in the pharmaceutical industry, beginning his career in 1995 as a system developer. Since 2002, he has specialized in quality assurance within a leading pharmaceutical CDMO, where he has overseen the validation and GxP compliance of global computerized systems. Throughout his career, Kurt has developed robust CSV and data integrity governance frameworks for international organizations, along with comprehensive training programs and risk-based methodologies. Holding a secondary degree in pharmaceutical validation technology, he effectively bridges the gap between IT/OT and GxP, offering a holistic approach to compliance and system integrity.

Jim Brooks

Jim Brooks

Lead Platform Product Manager for GxP Strategy, IDBS

Jim has over two decades of experience in the BioPharma sector, and is currently the Lead Platform Product Manager for GxP Strategy at IDBS. In this role, he leads initiatives that help customers achieve and sustain compliance with GxP computerized system regulations. His career spans roles in Quality Control, Quality Assurance and IT, where he has been instrumental in validating, deploying and managing laboratory information systems in regulated environments. Jim’s deep understanding of GxP requirements and his cross-functional expertise make him a key contributor to advancing compliance strategies in the life sciences industry.