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FDA

When FDA inspects a medical device manufacturer, it determines whether or not its employees know what they should be doing and actually do it.

When FDA inspects a medical device manufacturer, it determines whether or not its employees know what they should be doing and actually do it. An FDA investigator will already know about your recalls, the root causes of your product problems and will quickly relate that information to device history records and QC rejection records. FDA can look at employees’ training records to determine whether they had the knowledge and skills to do their job and whether or not it is related to product problems. Training records, or the absence of training, quickly reveal whether the firm truly supports training and QSR conformance. The FDA will hold executive management responsible for training failures, especially as it relates to supporting the firm’s Quality Assurance (QA) program. FDA will ask employees about their training; ask you to see training records, challenge your QA program and at the conclusion of the inspection indicate how management has failed to do its job in this regard. Management responsibility is a well established legal principle in FDA law. The agency does not hesitate to use it.Areas Covered in the Session :Legal basis for the QSR training requirementTraining assessment and evaluation criteriaFDA inspection and evidence developmentFDA discussion with management.Price Tags:LiveSingle Live : For One Participant$ 249Corporate Live : For Max. 10 Participants$ 899RecordingSingle REC : For One Participant - Unlimited Access for 6 Months$ 299For bookings and more information contactCompliance Trainings,5939 Candlebrook Ct, Mississauga, ON L5V 2V5, CanadaContact:  4169154458

When

18 May 2014 @ 01:00 am

19 May 2014 @ 02:00 am

Duration: 1 days, 1 hours

Timezone: GMT -8:00


Where

Online Webinar


Organised by

Compliance Trainings (deactivated)

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