Device Working Group

The objective of the Device Working Group is to understand and promote best practices for OINDP device design. The Working Group was formed to prepare and conduct a Device Design session at the IPAC-RS 2008 Conference, and has since written and published a paper on the same topic, developed and conducted a survey on testing needed to support device changes, and presented at the IPAC-RS 2011 conference on the topics of "Regulatory Expectations for User Testing" and "Human Factors and the Design of Inhalation Devices." Human factors and device design, testing needed to support device changes, and environmental sustainability are among the Working Group's current initiatives.

Publications

• Device Development and Design Control for Combination Products: Standards, Regulations and Current Practices for Orally Inhaled and Nasal Drug Products.



• International approaches to regulation and quality standards for orally inhaled and nasal drug products Inhalation. December 2009.
  
  
• Risk Management for Combination Products. The need for improved risk management practices for orally inhaled and nasal drug product. Inhalation. October 2009, pp. 12-15.