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Online Webinar
20 Jan 2011

Webinar On Device Master Record

This webinar explains these requirements from QSR and explains the role of each document type. The webinar uses the QSR preamble to explore FDA

Why Should You Attend: The FDA’s QSR expects the manufacturer to maintain a series of documents that describe the design and production of the device. These are Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), and Quality System Record (QSR). An FDA inspection will focus on the records you maintain. These records provide the objective evidence that demonstrates your QMS operates the way it should. While procedures are important, the supporting records demonstrate that you follow your own procedures.Areas Covered in the Seminar:The FDA’s QSR. The source of the requirementsThe preambleThe QSR ManualOMB information collectionKey DefinitionsDesign History File (DHF). RequirementsContentQuality System Record (QSR) 


20 Jan 2011 @ 08:00 am

20 Jan 2011 @ 09:15 am

Duration: 1 hours, 15 minutes



Online Webinar


English en

Organised by

ComplianceOnline (deactivated)

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