Events

AdvaMed Workshop: MEDICAL DEVICE COMPLAINTS, MDRS AND REPORTS

Advamed

 

This workshop has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion

FDA staff and industry experts are coming together to teach you about:

– Elements of an effective complaint management system
– FDA’s expectation about trending complaints from non-US markets
– How to ensure that your electronic records database handling complaints complies with 21 CFR Part 11- How to investigate complaints to determine if they are MDR’s
– The dos and don’ts when informing FDA of a product problem
– FDA’s involvement in health hazard evaluation and classification
– And more…

Registration fee includes access to presenter materials and slides, meals (breakfast&lunch), and a networking reception.

RN