Technology, automation, and advanced usages of data are sweeping the global pharmaceutical industry, ushering in an era of innovation that is revolutionizing the way we monitor, diagnose, and treat patients all over the world. Equal to the hope and promise of innovative new medicines is the abiding benefit of mainstay treatments that have long enhanced people’s lives.
Realizing the healthcare mission to provide safe, effective, and quality drug products through GMP compliance is inextricable from data integrity, and thus data integrity remains at the forefront of concern to Health Authorities and manufacturers alike. Data governance is fast replacing earlier approaches to data integrity and is now the Regulatory expectation as a holistic way organizations can “build-in” data integrity compliance by design. Assuring data integrity compliance as an output of an intentional, risk-based scheme addressing people, processes, and technical controls, enables organizations to maintain compliance and meet quality attributes across an ever-growing ecosystem of data assets.
More and more, the influence of Quality Culture is at the forefront of the adoption of successful data governance. Regulatory guidance for data integrity suggests that a lack of leadership and Quality Culture can lead to a breakdown of quality systems and data integrity lapses. Thus, Health Authorities’ increased focus on the link between successful data governance and Quality Culture has become increasingly evident in enforcement actions such as Warning Letters. This “link” is further supported by leading research such as PDA’s Quality Culture Survey Report and St. Gallen’s “Impact of Quality Culture on Operational Performance”. Leadership responsibilities, organizational procedures, personnel behaviors, knowledge/risk and data management, and technical controls, must all be leveraged across data governance and Quality Culture strategies if data integrity compliance objectives are to be achieved.
This Workshop will be comprised of interactive case studies, presentations, and panel discussions addressing strategic and tactical elements of Data Governance with a focused lens on Quality Culture attributes. Speakers will share on a variety of topics including management responsibility, data governance programs, monitoring data integrity and cultural risk, “inspecting” culture, maturity models, enabling change, and advanced data usage. Come join us to share experiences, learnings, and ideas.