WEBINAR: Wednesday, March 28, 2012 1:00 pm, Eastern Daylight Time (Indiana, GMT-04:00)
Panelists: Roger Martin, Founder of Compliance Dynamics, http://www.mycdyn.com and Chuck McGinley, Sr.Applications Engineer for Omnify Software. http://www.omnifysoft.comFDA statistics show that 45 to 50 percent of all device recalls stemmed from poor product design. Design controls are not only a regulatory requirement, they lay the foundation for the proper design and development of medical devices and can provide device manufacturers with the opportunity to address and/or correct problems early in the process.
Learn how to implement effective and efficient product development procedures with Product Lifecycle Management (PLM) technology in order to ensure compliant design controls, address design control challenges, simplify the audit process, and reduce the cost of compliance through automated enterprise resource systems and best practices.
- ISO and FDA Design Control requirements
- Compliance documentation requirements
- Recommendations to effectively meet the requirements of design control
- Integrating Design Controls into the business of best in class New Product Development (NPD)
- Demonstration of PLM technology supporting best practice Design Controls
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