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Welcome to the Advanced Manufacturing West 2019 Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

Building a Risk-Based Culture to Improve Quality

Thomas Bento (Senior Vice President of Quality and Regulatory Assurance, Nihon Kohden America)

Location: 210D

Date: Wednesday, February 6

Time: 1:15pm - 2:00pm

Track: MD&M West: Regulatory & Quality Update

Vault Recording: TBD

Critical to today’s new product development processes are methods for applying risk-based decision making. This session will cover techniques to combine risk management and design requirements to ensure appropriate risk mitigation activities are taken into effect within product design.

Topics covered include:
  • Moving from a regulatory compliance mindset to a consumer mindset to improve risk in product design and development
  • Implementing a strong quality system architecture to ensure connectivity between each quality system element
  • Leveraging data from complaints and post-market surveillance activity into quality management system design to ensure in future comprehensive risk assessments.
  • Analysis of 21CFR820 FDA guidance on quality systems and ISO14971 on design control processes to ensure compliance with quality control and risk management requirements