Quality Culture

Advancing Pharmaceutical Quality continues to be a hot topic as industry sees the benefit in an industry-for-industry program to advance continual improvement. FDA is reflecting on the messages it is hearing in response to the 2018 Federal Register...

Teamwork and collaboration are becoming increasingly critical in today’s professional arena. The drive to produce innovative, disruptive products calls for interdisciplinary teams. To function effectively, these diverse groups require creative problem-solving, conflict resolution, and interpersonal...

A corporate culture that supports creative thinking can help pave a road to innovation. Free people from fear and encourage them to do their best and you’ll have an environment for accomplishing great things, according to George Scangos, who has led Biogen and other pharma companies. In a recent...

FDA wants us to instill a strong quality culture in our operations.  To track our progress toward that strong quality culture we have been asked to measure quality parameters.  Those metrics are presumed to reflect the underlying quality culture of an...

Shaping Excellence: How Leader Actions and Behaviors Influence Quality Culture Part 2 Quarterly Report on Quality Culture This article was published in the November/December 2016 edition of Pharmaceutical Engineering® magazine in the Quarterly Report...

Shaping Excellence: How Leader Actions and Behaviors Influence Quality Culture Part 1 Quarterly Report on Quality Culture This article was published in the November/December 2016 edition of Pharmaceutical Engineering® magazine in the Quarterly Report...

The pharmaceutical industry is facing a restructuring in quality management.  The manufacturing goal of producing consistent, high-quality products with minimal regulatory oversight is revealing a new path. The FDA and CDER are in the process of...