Development and Audit of Complaint Handling and MDR Processes - ComplianceOnline (Complaint Handling a)

Venue: Online

Location: Palo Alto, California, United States

Event Date/Time: Apr 24, 2009
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Description

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.

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Additional Information

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.