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Upcoming Seminars

July 30 & 31, 2015
Philadelphia, PA

Dan O'Leary
Statistical Techniques for Medical Device Manufacturers

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."


August 6th & 7th, 2015

John Zorich
The Statistics of: Design Verification, Process Validation, and Statistical Process Control

This 2-day seminar provides a 1-day introduction to the statistical tools used to analyze Design Verification data and Process Validation results. The 2nd day is spent on Statistical Process Control and Process Capability Indices.


October 1st & 2nd, 2015
Washington, DC

Casper Uldriks
Tougher Import Rules for FDA Imports in 2015

FDA's and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures.


October 22nd & 23rd, 2015
Los Angeles, CA

David R. Dills
Complaint-Handling, MDR and Recall Management

An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.



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