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PDA’s 4th Metrics Conference: Measuring the State of Quality Metrics

Tuesday 25 July 2017

Quality metrics remain a hot topic. In February 2017, Stephanie Gaulding, Principal Consultant at DPS attended the 2017 PDA Quality Metrics and Quality Culture Conference in Bethesda, Md. The July-August issue of PDA letter includes an article written by Stephanie.

The article includes summaries of presentations and discussion from both days of the conference, covering topics such as:

  • The purpose of the proposed FDA quality metrics program and desire to create a culture of dialog between industry and the FDA around quality metrics
  • Although not mentioned in current guidance, quality culture still important
  • Initial results from pilot of PDA quality culture assessment tool

Stephanie has over 20 years quality and regulatory compliance experience in the pharmaceutical, biotechnology, and medical device industries. She helps clients develop, redesign, and implement efficient and sustainable quality systems as well as successfully preparing for and navigating regulatory inspections. 

The PDA article can be found here, or to view the original article, connect with Stephanie through her LinkedIn profile.