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