This 90-minute webinar discusses the exciting new program of “Corporate Data Governance” that is being implemented within and outside the GXP-regulated industries as all organizations increasingly appreciate the importance and value of accurate, consistent, and reliable data for effective decision-making. To achieve this, many companies are developing data process maps as “useful tools” (ref: ICH Q10) in their Corporate Data Integrity Governance Programs. The exercise of mapping data processes, assessing data integrity risks, reducing risks by implementing mitigating controls, continuously reviewing risks, and reducing residual data integrity risk applies to all GXP-regulated activities across the entire product life cycle. This webinar will discuss these principles and potential pitfalls associated with various approaches to building reliable ‘end-to-end’ data life cycles for effective knowledge management. This webinar provides 15 minutes for Q&A.
Example topics include:
• Where does Data Life Cycle fit into the Quality Management System?
• Quality Risk Management of Data Life Cycle
• Process Mapping Tools
• Defining “Critical” Data and “Meaningful” Metadata
• Assessing Controls to Prevent & Detect Data Integrity Issues during Inspections of Data Processes
• Case Studies