ISPE Conference on Quality Culture and Quality Metrics, 25-26 April 2017, Bethesda Marriot, Bethesda MD

2017 ISPE Conference on Quality Culture and Quality Metrics

The 2017 ISPE Conference on Quality Culture and Quality Metrics, which coincides with the publication of ISPE’s Cultural Excellence report, will provide a collection of practical, powerful tools and a comprehensive behavior-based approach for improving quality culture as a means of delivering enhanced quality outcomes. The conference will also feature high-level sessions, aligned with the FDA’s revised draft guidance on Quality Metrics and ISPE’s on-going Quality Metrics Initiative, providing the latest data and insights for operationalization of quality metrics across the supply chain. In our increasingly complex global pharmaceutical world, our supply chains include multiple nodes and suppliers that need to be carefully considered in launching our quality metrics programs across industry.  

“The degree to which quality is embedded in an organization’s culture can mean the difference between success and failure.”

- François Sallans, Johnson & Johnson

Why Attend?

The influence of an organization’s quality culture has emerged as a key enabler from the recent public discourse on measuring performance and quality metrics for delivering outcomes that matter to the patient.

Cultural excellence requires that all employees are passionate about eliminating mistakes by making quality their driving principle.  It goes beyond following the content of the quality policies and procedures by creating an environment that is focused on continuous improvement and learning.

Examining the powerful force that culture exerts on day-to-day operations within organizations, ISPE’s Quality Culture Team has established that although for many the concept of quality culture remains abstract, the behavioral impacts are very real indeed.

At the 2017 ISPE Conference on Quality Culture and Quality Metrics, you will learn from the experiences of your industry peers through case studies and the sharing of best practices how to:

  • Implement the practical approaches and tools compiled in the Cultural Excellence report
  • Lead and/or actively contribute to shaping quality culture in your company
  • Enable a collective mindset for improving quality
  • Practice Gemba as a key strategy for coaching and mentoring desired attitudes and behaviors
  • Use a practical new tool to target and measure the behaviors that matter
  • Put in place effective management oversight and review practices
  • Identify critical enablers that are necessary to build and sustain a culture of excellence
  • Interpret research and insights on quality metrics
  • Apply valuable experiences and strategies on quality metrics

Who Should Attend?

While this conference will be directly relevant for those who have responsibility for Quality Cultural improvement programs and Quality Metrics, it will also be of particular interest to professionals working in the following areas:

  • Global and Site Quality Leadership
  • Manufacturing
  • Packaging
  • Quality Control Operations Leadership
  • Operational Excellence
  • Oversight and Selection of the External Manufacturing Network Management
  • Supply Chain Management
  • M & A Due Diligence

Thank you to Our Program Committee!

Committee Chairs

Nuala Calnan, PhD Photograph
Nuala Calnan, PhD
Regulatory Science Adjunct Research Fellow
School of Chemical & Pharmaceutical Sciences
Dublin Institute of Technology
Matt Pearson Photograph
Matt Pearson
Senior Director
Global Quality Continuous Improvement
Genentech, Inc.

Committee Members

Erika Ballman Photograph
Erika Ballman
Quality Assurance Site Manager
Quality Assurance and Regulatory
Albemarle
Kira Ford Photograph
Kira Ford
Director
Global Quality Systems
Eli Lilly and Company
Margit Schwalbe-Fehl, PhD Photograph
Margit Schwalbe-Fehl, PhD
Managing Partner
Bridge Associates International, LLC
Tami Frederick Photograph
Tami Frederick
Global Director
Corporate Quality Systems
Perrigo

Additional Contributors

  • Stuart du Kamp, Director, Quality Compliance, Septodont
  • Joseph Kuntz, Senior Manager, COQA, Pfizer
  • Andrew Mens, Director, Regulatory Compliance, Johnson & Johnson
  • T. David Hansen, Director, Regulatory Compliance, Johnson & Johnson
  • Brianna Peterson, Global Quality, Quality Culture Project Manager, Boehringer Ingelheim
  • Leslie Sam, Director, Global Quality Systems, Safety, Efficacy and Customer Information at Eli Lilly and Company
  • Bart Shrode, Vice President, Quality Operations, Perrigo
  • Kent Brown, Senior Advisor and Global Head Inspection Management and Platform Support, Novartis
  • Claudia Sigg, Head of Quality Projects, Boehringer-Ingelheim

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Presentations & Attendee Roster

Conference Attendees:

Keynote Speakers

Mark Birse Photograph
Mark Birse
Group Manager Inspectorate, Inspection, Enforcement & Standards Division, MHRA
Shane Yount Photograph
Shane Yount
Chief Operating Officer, Principal, Competitive Solutions, Inc.
Louis Yu,PhD Photograph
Louis Yu, PhD
Chief Quality Officer, Valeant Pharmaceuticals International, Inc.

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