ISPE hosted a successful Quality Metrics Pharma Workshop facilitating cross-industry dialog on 3 March 2017 on the Novartis campus in New Hanover, NJ, with excellent cross-industry representation and lively engagement.

ISPE Quality Metrics Pharma Workshop at Novartis Facilitates DialogThe day’s program was kicked off with remarks by Tara Gooen Bizjak, FDA Senior Policy Advisor.  Tara stressed that quality metrics are a key element of the FDA’s 21st Century Pharmaceutical Quality initiative, and emphasized the value of the data derived from ISPE’s Quality Metrics Pilot Program  coupled with open dialogue with the pharmaceutical industry.   Tara thanked ISPE for hosting the workshop and noted that these industry discussions and working group meetings are not only valuable but aligned with FDA’s vision of the pharmaceutical industry leading quality metrics forward.

The workshop participants represented the companies that participated in ISPE’s Pilot Program. The attendees included senior leaders who are driving their company’s strategy, as well as some of their colleagues who are keenly focused on operationalization of the FDA Quality Metrics Program within those companies.  The workshop was focused on four key topics:

  • Submission of regulatory metrics
  • Data validation and preparation for inspection
  • Leading and other key indicators to support assessment and continual improvement of quality
  • Ideas for future industry engagement

Attendees provided input on each topic in a series of breakout sessions, and identified follow up activities to be matured and actioned.

ISPE Quality Metrics Pharma Workshop at Novartis Facilitates DialogThe opportunity to connect with industry peers and share best practices was highly appreciated and was a resonating theme throughout the discussions as the attendees acknowledged the value of the insights gained. The benefit of connecting and benchmarking at strategic and operational, qualitative and quantitative levels was recognized as a positive impact that the FDA Quality Metrics Program has delivered.

The workshop participants expressed substantial interest in continued engagement. ISPE anticipates conducting another workshop in Q4 of 2017, also in the tristate area.

Want to learn more about how your organization can be involved with continuing the discussion within the pharmaceutical industry and with regulators?  Check out two upcoming conferences designed to continue the conversation:

2017 Conference on Quality Culture and Quality Metrics

The 2017 ISPE Conference on Quality Culture and Quality Metrics  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 provide the latest data and insights for operationalization of quality metrics across the supply chain.

2017 ISPE/FDA/PQRI Quality Manufacturing Conference

The 5th Annual ISPE/FDA/PQRI Quality Manufacturing Conference  offers you the unique opportunity to interact directly with industry and regulatory leaders to identify real solutions to your organization’s challenges on key issues. Sessions are designed to encourage open discussion about current FDA priorities and industry-critical quality initiatives.

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