Design Control for Medical Devices

Starts: Thursday March 18, 2010 at 8:30am
Ends: Friday March 19, 2010 at 5:30pm
Event Type: Training/Seminar
Region: Las Vegas, Nevada Area
Location: Rio All-Suite Hotel & Casino
3700 W Flamingo Rd
Las Vegas, NV 89103 US
Price: $1,980
Website: http://www.EduQuest.net/designcontrol.htm
Industry: medical device
Keywords: Qsr, Design Transfer, Quality System, Qc, 21 Cfr 820, Fda Audit, Fda, Medical Device, Design Control, Qa, Fda Compliance, Iso, Fda Inspection
Intended For: Designed specifically to help device industry managers, engineers, QA/QC specialists, and regulatory affairs professionals improve their company’s compliance with FDA’s 21 CFR 820 Quality System Regulation.
Organization: Learn FDA Rules for Quality Design and Manufacturing

Design control is required for all medical devices sold in the U.S., EU, Japan, and several other countries. In addition, there’s relentless pressure from both FDA and Congress to improve device design control and manufacturing.

By attending the Design Control course, you learn how FDA expects you to develop, implement, and manage design control. You also focus on overcoming one of the biggest obstacles that regularly confounds device companies – accurate and consistent transfer of product design to actual manufacturing operations. Moreover, you learn how FDA’s design control rules relate to product quality standards established in ISO 9001:2000 and ISO 13485.