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

Quality Culture and Quality Metrics Education

Join experts from the FDA and MHRA and 20+ pharmaceutical companies for two days of valuable knowledge-sharing and networking, featuring:

  • 2 keynote sessions
  • 2 industry panel discussions
  • Featured sessions on quality metrics
  • Interactive workshops focused on the Six Dimensions Framework in the Cultural Excellence report

Tuesday, 25 April

0830 - 1000  Opening Keynote Session
1000 - 1030  Networking Break
1030 - 1115  Inspirational Keynote Session

This keynote will focus on practical approaches to driving a culture of consistency, clarity and connectivity to transform business results and continually improve quality culture.
1115 - 1215  Workshop 1: Leadership & Vision

This interactive session will explore the impact leadership and vision has on shaping cultural excellence, while offering key insights, practical tools and case studies on cultural transformation through leadership and vision.
1215 - 1315  Lunch
1315 - 1415  Workshop 2: Mindsets & Attitudes

This workshop will explore the dimension of mindset & attitudes and their influence on cultural performance. It will focus on sharing practical tools and approaches to help leaders shape quality mindset and culture.
1415 - 1515  Workshop 3: Gemba Walks/Engagement

This session will explore the power of management engagement with frontline personnel through Gemba in shaping quality culture and mindset. It will focus on case studies and pragmatic approaches to improving employee quality ownership and speak up culture.
1515 - 1545  Networking Break
1545 - 1800  Quality Metrics Interconnectivity with Quality Culture- Current perspectives from ISPE and FDA

This session on Quality Metrics provides an overview of the ISPE response to the most recent draft guidance, compiled based on rich input from ISPE members representing all segments of the pharmaceutical industry. The session also reflects on the continued relevance and powerful insights gained from the ISPE Quality Metrics Pilot programs where it was strongly demonstrated that robust quality culture is a strong influencer of Outcome metrics such as those included in the current FDA draft guidance. Finally, the session will lead the delegates through discussions on the necessity for continued focus on quality culture and other leading indicators that companies have seen to be discriminating and predictive.

Delegates will gain:
  • Understanding of the ISPE member's comments to the most recent draft guidance issued Nov 2016
  • Insights into the strong correlation between strong performance on these outcome metrics with the underpinning Quality Culture and other leading internal outcomes
  • Industry role in focusing not just on the reportable data but managing the levers that drive the reported outcomes
1800 - 1900  Networking Reception

Wednesday, 26 April

0830 - 1030  Keynote Session and the Shaping Excellence Leaders Panel
  • Leader: Nuala Calnan, PhD, Regulatory Science Adjunct Research Fellow, Dublin Institute of Technology, Ireland
    Interactive Summary/Feedback- Key Questions and Take-Aways from Day 1
  • Vivianne Arencibia, VP, Global Head, Group Quality Audit and Compliance, Novartis, USA
    Shaping Excellence Leaders Panelist
  • Michael Arnold, RPh, Chair- ISPE Board of Directors, Investigational Product Business Process Owner, Pfizer Global Clinical Supplies, USA
    Shaping Excellence Leaders Panelist
  • Erika Ballman, Quality and Regulatory Site Manager, Albemarle, USA
    Shaping Excellence Leader Panel
  • Mark Birse, Group Manager Inspectorate, MHRA, United Kingdom
    Quality Culture- Regulatory Push or Pull?
  • Machelle Eppler, Vice President and Head of Global Quality Compliance & Regulatory, Patheon, USA
    Shaping Excellence Leaders Panelist
  • Richard Friedman, Deputy Director, Science and Regulatory Policy, FDA/CDER/OC/OMQ, USA
    Shaping Excellence Leaders Panelist
  • François Sallans, PharmD, VP Quality & Compliance, Chief Quality Officer, Johnson & Johnson, USA
    Shaping Excellence Leaders Panelist
  • Pamela Viscione, BSCE, MS, Director, Quality Assurance, The Procter & Gamble Company, USA
    Shaping Excellence Leaders Panelist
  • Louis Yu, PhD, Chief Quality Officer, Global Quality and Compliance, Valeant Pharmaceuticals International, USA
    Shaping Excellence Leaders Panelist
1030 - 1100  Networking Break
1100 - 1200  Workshop 4: Measuring LQIs and Triggers

This workshop will explore the role of Leading Quality Indicators (LQI's) and Triggers in shaping cultural excellence. It will focus on how to develop leading behavioral based metrics to help foster and measure a healthy quality culture.
  • Nuala Calnan, PhD, Regulatory Science Adjunct Research Fellow, Dublin Institute of Technology, Ireland
    Leading Quality Indicators and Triggers- Measuring What Matters
  • Anne Greene, PhD, Lecturer, Dublin Institute of Technology, Ireland
  • Joseph Kuntz, Senior Director, Contract Operations Quality Assurance, Pfizer Inc., USA
1200 - 1300  Lunch
1300 - 1400  Workshop 5: Oversight & Review

This workshop will explore the important role that oversight and review have in fostering quality culture. It will focus on sharing powerful tools, best practices and case studies to help improve cultural performance through oversight and review.
1400 - 1430  Networking Break
1430 - 1530  Workshop 6: Cultural Enablers

This workshop will explore the importance of installing and aligning cultural enablers to support desired quality behaviors and culture. It will discuss the foundations necessary to foster and encourage a healthy quality culture.
  • Tami Frederick, Global Director, Corporate Quality Systems, Perrigo Company, USA
    Shaping Quality Culture Excellence:Cultural Enablers
1530 - 1630  Closing Panel Discussion with Q&A
  • Erika Ballman, Quality and Regulatory Site Manager, Albemarle, USA
  • Nuala Calnan, PhD, Regulatory Science Adjunct Research Fellow, Dublin Institute of Technology, Ireland
    Conference Summary and Closing Panel Discussion
  • Kira Ford, B.S., Director, Global Quality Systems, Eli Lilly & Co Mfg & Quality Learning Ctr , USA
  • Tami Frederick, Global Director, Corporate Quality Systems, Perrigo Company, USA
  • Matthew Pearson, Senior Director, Genentech, USA
  • Margit Schwalbe-Fehl, PhD, Managing Partner, Bridge Associates International LLC, USA

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.

Join ISPE today and save hundreds of dollars on registration as well as enjoy other great membership benefits.

Join now!

Receive Notifications

Stay up-to-date on education sessions, speakers, hotel discounts, exhibitor information, and more by signing up to receive notifications for the 2017 Conference on Quality Culture and Quality Metrics.

*Required