ISPE Releases The New Cultural Excellence Report

ISPE, the International Society for Pharmaceutical Engineering, released a new Cultural Excellence Report announced at its Conference on Quality Culture and Quality Metrics in Bethesda, Maryland, 25 April 2017. Cultural excellence recognizes quality not as an operational burden or compliance requirement, but as a necessity that allows companies to make decisions that are in the best interest of the patient.

The ISPE Cultural Excellence Report shares the vision of quality culture improvements across six dimensions and outlines a series of practical and powerful approaches, practices, and tools to support implementation of the cultural excellence framework, and promote behavioral change that will benefit the patient. “ISPE believes the tools shared in this report provide a practical frame of reference for companies that want to build healthy quality cultures within their organizations”, said John Bournas, ISPE CEO and President.

The ISPE Quality Culture Subteam, sponsored by the ISPE Quality Metrics Team and co-led by Dr. Nuala Calnan of the Dublin Institute of Technology and Matt Pearson of Genentech, created this extensive report. The Cultural Excellence Report concentrates on six dimensions of cultural excellence – Leadership and Vision, Mindset and Attitudes, Gemba Walk, Leading Quality Indicators and Triggers, Oversight and Review, and Structural Enablers - a framework first introduced at the ISPE Quality Metrics Summit in April 2015.

Dr. Calnan explained “The ISPE Cultural Excellence program was aimed at promoting, coaching, and leading specific desired behaviors while identifying and preventing specific undesired behaviors.”

The ISPE Quality Culture Subteam prepared the corporate culture gap analysis from the ISPE Drug Shortage Assessment and Prevention Tool to establish a set of 21 desired key behaviors that support the six dimensions of cultural excellence. The assessment tool featured in the report was designed to help organizations assess the maturity of these behaviors as part of their quality culture program.

This report is available in PDF format. The report is $49 for nonmembers.

For more information on the ISPE Cultural Excellence Report, please visit the ISPE Bookstore.

About ISPE

The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical life cycle. The more than 18,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Bethesda, Maryland, USA, and an operations and training center in Tampa, Florida, USA. Visit www.ISPE.org for more information.

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