戻る Agenda
Developing and Embracing a Culture of Quality in the Pharmaceutical Industry
Session Chair(s)
Mary Oates, PHD
Vice President, Innovative Operations and Network Excellence
Pfizer Inc, United States
Reliable availability of quality medicines requires more than following the rules laid down by regulators. Today’s complex, global environment demands that all participants in the supply chain adopt a culture of quality, a culture in which every employee understands and embraces their responsibility for delivering quality outcomes that benefit patients. This focus on quality outcomes must exist across the product life cycle, including product and process development, clinical trials, regulatory submissions and commercial manufacturing. The session will define the characteristics of a quality culture across a range of firms and functions, describe how to assess existing culture and achieve the desired state and outline the benefits for patients, regulators and the pharmaceutical industry.
Learning Objective : Define the characteristics of a quality culture; Recognize knowledge and tools that will facilitate culture enhancement.
Speaker(s)
FDA Point of View on Culture of Quality
Christine Moore, PHD
Organon & Co., United States
Executive Director, Global External Advocacy and Standards
Quantifying Quality Culture at an API CMO
Guy Villax
Hovione , Portugal
Chief Executive Officer
Developing and Embracing a Culture of Quality Beyond the Manufacturing Environment
David A. Tainsh, PHD, RPH
GlaxoSmithKline, United Kingdom
Chief Product Quality Officer, Governance, Ethics and Assurance