Live Q&A (C5)

Could a pirate shortage be the cause of global warming? And does eating cheese increase your risk of strangulation? Sound strange? It’s real data! In the pharmaceutical industry, it’s often said that we make two products. The physical medication that is taken by the patient and the data to support it. It’s imperative that our patients trust that data.

“All That Data . . . Now What?” will emphasize the fundamental principles of data management and highlight data integrity as a key attribute of operational excellence. Most companies have programs to monitor and look for data integrity lapses. But how do we move from this reactive model to one where data integrity is inherently integrated into our Quality Management System, driving process efficiency and facilitating data-driven decision making through implementation of process-appropriate controls? This session will focus on key concepts of the forthcoming PDA Technical Report on data integrity in quality management systems, and PDA TR84, Integrating Data Integrity Requirements into Manufacturing & Packaging Operations. Industry presenters will demonstrate how implementation of these concepts drives improvements in operational understanding and control. The presentations will be followed by an active panel discussion with both industry and agency representation.