The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: July 30, 2015 at 9am to July 31, 2015 at 6pm
Location: DoubleTree by Hilton Hotel Philadelphia Center City
Street: 237 South Broad Street, Philadelphia, Pennsylvania, 19107-5686, USA
Website or Map: https://www.globalcompliancep…
Event Type: clinical, food, fda, medical, device, defence, and, navy, aerospace, mining
Organized By: John Robinson
Latest Activity: Apr 22, 2015
The FDA's Quality System Regulation (QSR) requires device manufacturers to identify valid statistical techniques to "establish, control, and verify the acceptability of process capability and product characteristics." When device manufacturers analyze CA&PA information, they must also use "appropriate statistical methodology". Some manufacturers are not clear about all of this. Others are nervous that their approach is sufficient.
The seminar starts with an understanding of the regulations through a variety of sources. This includes the Quality System Inspection Technique (QSIT) as well as Warning Letters.
All medical device manufacturers that apply FDA QSR or ISO 13485:2003
Dan O'Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs.
Location: Philadelphia, PA Date: July 30 & 31, 2015 Time: 9:00 AM to 6:00 PM EDT
Venue: DoubleTree by Hilton Hotel Philadelphia Center City
Venue Address: 237 South Broad Street, Philadelphia, Pennsylvania, 19107-5686, USA
Price: $1,295.00 (Seminar for One Delegate)
Register now and save $200. (Early Bird)
Until April 30, Early Bird Price: $1,295.00
From May 01 to July 28, Regular Price: $1,495.00
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
USA Phone: 800-447-9407
Event Registration Link - http://bit.ly/1zzZDvv