Complaint Handling in Compliance with FDA and ISO Regulations - Webinar By ComplianceOnline (Quality Management T)
Venue: Online Event
|Event Date/Time: Jul 11, 2011||End Date/Time: Jul 11, 2011|
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.
Areas Covered in the Seminar:
- FDA and ISO requirements for complaint handling.
- Establishment of complaint handling program.
- What constitutes a complaint.
- ISO-specific implications of complaint handling.
- The roles of investigation and corrective action in complaint handling.
- Complaint trending and reporting.
- Application of risk management to complaint handling program.
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