Statistical Techniques for Medical Device Manufacturers at Philadelphia

Event Details

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
City/Town: Philadelphia
Website or Map: https://www.globalcompliancep…
Phone: 18004479407
Event Type: clinical, food, fda, medical, device, defence, and, navy, aerospace, mining
Organized By: John Robinson
Latest Activity: Apr 22, 2015

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Event Description

Overview:

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.

Why you should attend:

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.

Who will benefit:

All medical device manufacturers that apply FDA QSR or ISO 13485:2003

Quality Managers
Quality Engineers
Quality Assurance and Quality Control
Regulatory Affairs Managers
Regulatory Affairs Professionals
R&D Managers
R&D Engineers
Product Design and Development
Operations Managers
Production Managers and Supervisors

Speaker:

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)

Until April 30, Early Bird Price: $1,295.00

From May 01 to July 28, Regular Price: $1,495.00

Contact Information:

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

USA Phone: 800-447-9407

Fax: 302-288-6884

support@globalcompliancepanel.com