World Conference Calendar

32801 Conferences

Best Practices in Complaint Management - Webinar by GlobalCompliancePanel

Added by davidross759 on 2010-08-12

Conference Dates:

Start Date Start Date: 2010-08-19
Last Date Last Day: 2010-08-19
Deadline for abstracts/proposals Deadline for abstracts/proposals: 2010-08-18

Conference Contact Info:

Contact Person Contact Person: Support
Email Email: support@globalcompliancepanel.com
Address Address: Online Training Webinar, Wilmington, DE, 19801, United States
Phone Tel: 800-447-9407
Phone Fax: 302-288-6884

Conference 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. 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 ISO-specific implications. This session will discuss 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. Additionally, the application of risk management to a complaint handling system will be reviewed, and a specific risk management system explained.
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