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Training Options  Duration: 60 Minutes   Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar) Price: $295.00 Refund Policy

by Jeff Kasoff 
Overview: Negative customer feedback about a product’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 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.

Areas Covered in the Session

• Definitions and Applications to Practice
• When is a Complaint NOT a Complaint?
• Receipt and Documentation of Complaints
• Review and Trending of Complaints
• Complaint Investigation
• CAPA Implications
• Complaint Closure
• MDR Events and Reporting Requirements

Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies, since complaint handling is a regulatory requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

• Regulatory Management
  
• QA Management
  
• Customer Service personnel
  
• Sales personnel
  
• Consultants
  
• Quality system auditors