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AdvaMed's Quality Culture Playbook Webinar

October 17, 2018

We invite you to join a complimentary webinar that joins medical device industry experts with FDA quality leads to explain how device manufacturers can develop and improve quality culture.

Device firms with strong quality culture see benefits like fewer costly mistakes, product quality improvements, customer satisfaction, and strong employee morale. But many firms struggle to develop, improve, and grow quality culture. We surveyed industry members and sought FDA input to develop a Quality Culture Playbook. This playbook offers flexible, adaptable practices that firms can deploy to implement, maintain, and improve quality culture. 

October 17, 2018 | 2:00 - 4:00pm


  • What quality culture is and why it matters
  • The behaviors that drive quality culture
  • The workstreams to operationalize quality culture behavior
  • Strategies to deploy a quality culture initiative


  • Joe Sapiente, Vice President, Quality Assurance & Regulatory Affairs, Hologic, Inc.
  • Prakash Patwardhan, Senior Director, Medtronic
  • Shahzad Saleem, Director, Lean Sigma Operational Quality, Medtronic
  • Kareem Elwakil, Director, Management Consulting, PwC
  • Francisco Vicenty, Case for Quality Program Manager, FDA

Q&A session to follow speaker presentations