Events for Food and Drug Administration (FDA)

FDA Medical Device Facilities Inspections: Complexities of Devices Leaves Little Room for Error

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Unique considerations for device inspections — understanding the FDA QSIT inspection strategy
Three steps to take to get to know your investigator before he/she arrives
Ten areas of concern when preparing for an FDA device inspection
Four key team members
Roles
Job titles
Level of knowledge
When to put them in place
Four things every employee must do during a device inspection
Documents required and not required, based on reason for inspection
Five principals for mock audits of device facilities
Seven guidelines for executive management and their representatives before and during a device inspection
The importance of a daily debriefing
12 tips for making them valuable
Five strategies for responding to Form 483s
Five steps to developing a corrective action strategy
Five principals of follow-up communications

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