Best Practices in Complaint Management: Complaint Handling in Compliance with FDA and ISO Regulations

Overview:

Complaint management is more than simply documenting customer concerns—it is a critical component of post-market surveillance and quality system effectiveness.

Both FDA regulations and ISO standards require organizations to establish formal procedures for complaint intake, evaluation, investigation, documentation, and closure. However, many companies struggle with defining what constitutes a complaint, managing “non-complaints,” ensuring investigations are adequate, and effectively trending complaint data.

This session will provide a practical framework for designing and maintaining an effective complaint handling program that meets regulatory expectations while providing meaningful insights into product quality and customer satisfaction.

Participants will gain practical tools for improving complaint investigations, integrating risk management principles, linking complaints to CAPA systems, and ensuring proper documentation to withstand regulatory inspections.

Why you should Attend:

Many organizations struggle with determining what qualifies as a complaint, how much investigation is required, and how complaints should be linked to risk management and CAPA systems.

Poor complaint handling can lead to:

• FDA Form 483 observations
• Warning Letters
• Product recalls
• Increased regulatory scrutiny
• Loss of customer trust

This webinar will help eliminate the fear, uncertainty, and doubt (FUD) surrounding complaint management by providing clear regulatory expectations and practical strategies for implementing a compliant and effective complaint handling program.

Participants will learn how to properly classify complaints, investigate issues, trend data, and use complaint information to drive continuous improvement.

Areas Covered in the Session:

• FDA regulatory expectations for complaint handling (21 CFR requirements)
• ISO requirements for complaint management (ISO 9001 / ISO 13485)
• Key components of an effective complaint handling program
• Defining what constitutes a complaint under regulatory requirements
• Handling and documenting “non-complaints” appropriately
• Complaint intake, evaluation, and documentation requirements
• Conducting effective complaint investigations
• Linking complaints to CAPA and quality system improvements
• Complaint trending, metrics, and reporting
• Application of risk management principles to complaint handling
• Complaint escalation and potential regulatory reporting considerations
• Benefits and potential risks of responding directly to customers
• Best practices for maintaining inspection-ready complaint file

Who Will Benefit:

• Quality Assurance Managers
• Quality Control Professionals
• Regulatory Affairs Specialists
• Complaint Handling Specialists
• CAPA Coordinators
• Post-Market Surveillance Teams
• Compliance Managers
• Manufacturing Managers
• Product Quality Engineers
• Supplier Quality Professionals
• Internal Auditors