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.
A firm must implement an effective system to capture, document, correct and trend complaints, and equally important, to evaluate and identify customer feedback as to whether it qualifies as an MDR event. This webinar will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action. Also addressed will be the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also contained will be a suggested method on including complaint trending into your firm's CAPA program. The application of risk management to a complaint handling system will be included.
Areas Covered in the Session:
FDA requirements for complaint handling
Establishment of complaint handling program
What constitutes a complaint
What constitutes an MDR event
Evaluation of feedback as MDR: gray areas
The roles of investigation and corrective action in complaint handling
Complaint trending and reporting
Application of risk management to complaint handling program
Who Will Benefit:This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
Any personnel who may have direct interaction with FDA officials