Live Webinar
Best Practices in Complaint Management
Overview:
Negative customer feedback about a medical device s performance
or safety is a strong indicator of whether a firm s manufacturing
process is in control.
This feedback is therefore...
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Live Webinar
Best Practices in Complaint Management
Overview:
Negative customer feedback about a medical device s performance
or safety is a strong indicator of whether a firm s manufacturing
process is in control.
This feedback is therefore subject to many
requirements in both the QSR and ISO 13485.
Failure to follow up
on complaints about medical devices is among the most frequently
cited observations on FDA-483s.
This session will include the
requirements for defining, documenting, and implementing a
complaint-handling system, including the requirements for complaint
review, investigation, and corrective action, as well as the ISOspecific implications.
Areas Covered in the Session:
l FDA and ISO requirements for complaint handling
l Establishment of complaint handling program
l What constitutes a complaint
l ISO-specific implications of complaint handling
l The roles of investigation and corrective action in complaint
handling
l Complaint trending and reporting
l Applica
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