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

Overview:

This session will include the requirements for all required cross-functional responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Also covered will be the application of risk management to a complaint handling system, and a specific risk management system explained.

This webinar contains a streamlined review of the regulations, allowing the majority of time to be spent on a detailed focus on critical process requirements for compliance with the regulations. Jeff will also call from his 30+ years of experience in this area to put forth recommendations for methods of documentation that are straightforward and compliant. Among these recommendations are contents of complaint records, root cause investigations, and corrective actions. This webinar also covers the application of risk management principles to complaint investigation.

Why you should Attend:

Complaint handling is likely one of the more cross-functional parts of your quality system: Customer Service may receive your customer complaints, Sales and Marketing may need to reach out to the customer for additional information, Regulatory Affairs may determine whether the complaint is reportable, QA may perform the root cause investigation, R&D or Manufacturing Engineering may need to be involved in the corrective action, and Quality Engineering may need to trend the complaints.

Many complaints include terminology that is unlikely to withstand an FDA or ISO audit, such as “isolated occurrence” and “low risk.” Further, from a business perspective, how do you let your customers know that you received their complaint, when you know that their next question may be the dreaded “What did you find out?” A compliant quality system has, as one of its supports, a robust complaint system that is both compliant and business-savvy. This webinar will address these issues and more.

Areas Covered in the Session:

• FDA and ISO requirements for complaint handling
• Establishment of complaint handling program
• What constitutes a complaint
• How to Handle “non-complaints”
• The roles of investigation and corrective action in complaint handling
• Complaint trending and reporting
• Application of risk management to complaint handling program
• Benefits/Detriments of a Reply to the Customer

Who Will Benefit:

• Your “complaint taker(s)” (responsibility differs among companies)
• Customer Service personnel
• Regulatory personnel
• Quality Engineering personnel
• Sales and Marketing personnel
• Customer Service personnel
• R&D personnel
• Manufacturing Engineering
• Executive Management
• Consultants 
• Quality system auditors