Course Description 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. In addition, sampling plans must be valid, documented, adequate, and reviewed based on changes.

Date : 30th November 2017 to 1st December 2017

Place : United States, Statistical techniques for medical device manufacturers (ocp)

Website :https://www.eventbrite.com/e/statistical-techniques-for-medical-device-manufacturers-ocp-tickets-33119231513?aff=NDT

Contact Person:Paula Edwards

Description:

Course Description 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". In addition, sampling plans must be valid, documented, adequate, and reviewed based on changes.

Course Description 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. In addition, sampling plans must be valid, documented, adequate, and reviewed based on changes. will be held in Statistical techniques for medical device manufacturers (ocp),United States on date 2017-12-01

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Deadline for abstracts/proposals : 29th November 2017

Keynote Speakers : Dan 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

Conference Highlights :Statistical techniques are powerful methods for medical device manufactures since they can help improve efficiency and effectiveness. Many techniques apply in a variety of situations. This workshop explains how to evaluate the situation, determine the correct technique and apply it. In addition, since there are regulatory requirements, the workshop includes the necessary documentation to satisfy audits and inspections.

Venue :San Francisco, CA, United States

Check the event website for more details.