Data Integrity remains a recurring topic in warning letters and remediation discussions. In many cases, the finding itself is only the visible part of a broader issue: unclear process flows, inconsistent documentation, missing ownership, weak traceability or controls that do not work as intended in daily practice.
In this webinar, we look behind the scenes of common Data Integrity-related compliance gaps. We will discuss which types of findings are often seen in warning letters, why such gaps can occur in everyday operations, and which questions teams should ask early to better understand their own processes, systems and responsibilities.
This session is a practical starting point for QA, QC, Manufacturing, IT/CSV and Quality Compliance teams that want to reflect on Data Integrity risks before they become larger remediation topics.
Dr. Tanja Küssau is a Data Integrity and Compliance expert specializing in Data Governance, and Risk Management in the pharmaceutical industry. She has led multi-site compliance projects, ensuring alignment with regulatory requirements e.g. from...
Sarah Wittmar is a Specialist at GxP-CC with deep expertise in Data Integrity, validation and pharmaceutical quality topics. She supports clients when data, system or process-related risks need to be understood, structured and translated into...