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

08:30 - 10:00  Opening Keynote Session
10:00 - 10:30  Networking Break
10:30 - 11:15  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.
11:15 - 12:15  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.
12:15 - 13:15  Lunch
13:15 - 14:15  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.
14:15 - 15:15  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.
15:15 - 15:45  Networking Break
15:45 - 18:00  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This session on Quality Metrics provides an overview of the ISPE response to the most recent draft guidance, compiled based on rich input from ISPE members representing all segments of the pharmaceutical industry.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that robust quality culture is a strong influencer of Outcome metrics such as those included in the current FDA draft guidance. FDA Quality Metrics and OPQ leadership will share their thoughts on the Quality Metrics program as defined. The FDA team will also address their continued commitment to industry's focus on quality culture and additional key indicators that inform product quality and continuous improvement. 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
  • Hear perspectives from FDA Quality Metrics Team and OPQ leadership related to the Quality metrics program and the critical predictive role of a robust quality culture
18:00 - 19:00  Networking Reception

Wednesday, 26 April

08:30 - 10:30  Keynote Session and Industry Leader 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, Head of Step Change Program, Novartis, USA
    Industry Leader Panelist
  • Michael Arnold, RPh, Chair- ISPE Board of Directors, Investigational Product Business Process Owner, Pfizer Global Clinical Supplies, USA
    Industry Leader Panelist
  • 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
    Industry Leader Panelist
  • François Sallans, PharmD, VP Quality & Compliance, Chief Quality Officer, Johnson & Johnson, USA
    Industry Leader Panelist
  • Pamela Viscione, BSCE, MS, Director, Quality Assurance, The Procter & Gamble Company, USA
    Industry Leader Panelist
  • Louis Yu, PhD, Chief Quality Officer, Global Quality and Compliance, Valeant Pharmaceuticals International, USA
    Industry Leader Panelist
10:30 - 11:00  Networking Break
11:00 - 12:00  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
  • Joseph Kuntz, Senior Director, Contract Operations Quality Assurance, Pfizer Inc., USA
12:00 - 13:00  Lunch
13:00 - 14:00  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.
14:00 - 14:30  Networking Break
14:30 - 15:30  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.
15:30 - 16:30  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
  • Kira Ford, B.S., Director, Global Quality Systems, Eli Lilly & Co, USA
  • Tami Frederick, Global Director, Corporate Quality Systems, Perrigo Company, USA
  • Matthew Pearson, Senior Director, Genentech, a Member of the Roche Group, USA
  • Margit Schwalbe-Fehl, PhD, Managing Partner, Bridge Associates International LLC, USA

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.
Lawrence Yu, PhD Photograph
Lawrence Yu, PhD
Deputy Director, FDA/CDER/OPQ
Louis Yu,PhD Photograph
Louis Yu, PhD
Chief Quality Officer, Valeant Pharmaceuticals International, Inc.

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