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March 11, 2015

FoREMS & More: A Review of the 2012 FDA Guidance on Minimizing Medication Errors through Product Design

The changing technological landscape of pharmaceutical product development has led to an increased focus on utilizing a systematic approach to minimizing medication errors relating to product design. By taking a proactive, systematic approach to product design, medication-related errors can be greatly reduced. The goal of the 2012 FDA guidance is to provide the industry with recommendations to help improve drug product and container closure design at the earliest stages of product development for all prescription and nonprescription drug products.

This webinar will focus on:

  • How pharmaceutical product design can enhance patient safety by reducing medication errors, adverse events, and patient harm
  • A systematic process, known as failure mode and effects analysis (FMEA), and how it is the basis for successful product design when trying to minimize patient-related medication errors


  • M. Kris Srinivasan, MD, MBA, M.Eng.HSE - Director, Clinical Consulting, ParagonRx, an inVentiv Health company

To view the playback of this webinar click here.

If you have questions please contact Jenna Sisler:

To speak to a ParagonRx team member about our monthly webinars
call 888.459.8080 or email