Quality AMAs Dr. Janet Woodcock made clear in her keynote presentation at the 2013 ISPE Annual Meeting in Washington DC, the Food and Drug Administration is invested in creating a Quality Culture inside organizations “from the shop floor to the boardroom.” While this is not a new message, the addition of hundreds of millions of dollars to the 2014 FDA budget from the Generic Drug Users Fee Amendment statutes, especially at a time when most government agencies are seeing budget cuts, speaks to the urgency for action.

For global organizations, the vision of a Quality Culture ‘across an entire organization’, is even more critical to the FDA, given that non US-based global manufacturing supply chains are used to manufacture 70% of the generic prescriptions used by the US public every day. Differences in customs and traditions can also come into play when looking to implement a Quality Culture across a global supply chain.

FDA comments aside, it is simply good business to address a sustainable Quality Culture and to institute consistent quality-based learning – learning that goes well beyond senior operators demonstrating SOPs to the junior operators in a plant. Instead, linking your operations to the good science and good data on which those processes are based, and showing all employees why processes are performed the way the SOPs are written.  This creates an environment that invites your manufacturing staff to interact, question and potentially spot quality risks before they become a problem.

Additionally, a Quality Culture does not come from teaching new skills and knowledge alone.  It is not reasonable to assume that competency comes without practice. Rather it happens when people change their behavior after they see the consequence of their decisions (in carefully developed scenarios) through the eyes of their peers.

Join us at the ISPE Annual Meeting in Las Vegas as we delve into this important industry issue, during the Quality Culture and Process Improvement session on Tuesday 14 October from 15.30 – 17.00.  The session will outline the key steps to look for in an educationally sound framework for instilling a sustainable Quality Culture across an operator and technician audience.

Building a quality of culture is only one key aspect of building a Robust Quality Management System (QMS). Additional Quality Systems sessions listed below provide an overview of several other key aspects of a robust quality management system (QMS) including practical solutions for implementation. Participants will gain a better understanding of how to use a QMS as a business driver and flawless QMS integration within your organization’s structure and processes.

  • Solutions for QbD and ASTM E2500 Implementation Monday, 13 October 12:30 – 14:30
  • Operations-Focused Quality System Optimization Sunday, 12 October 13:00 – 15:00
  • How Good is Your Auditing System? Monday, 13 October 09:30 – 11:00
  • Operational Excellence: Strategies for Readiness Monday, 13 October 15:30 – 17:30
  • Key elements of a Quality System Tuesday, 14 October 08:15 – 09:30
  • Should All Quality Processes Move to the Cloud? Tuesday, 14 October 10:15 – 11:30
  • Quality Culture & Continuous Improvement – Part I Tuesday, 14 October 13:00 – 14:30
  • Quality Culture and Process Improvement – Part II Tuesday, 14 October 15:30 – 17:00
  • Translating Laboratory Developed Visible Residue Limits (VRL) to the Manufacturing Floor Wednesday, 15 October 08:00 – 09:15

Learn more about the education sessions planned at this year’s Annual Meeting by going to http://www.ispe.org/2014-annual-meeting