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! This session will include the requirements for all of the above 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. Attention will be paid to the application of risk management to a complaint handling system, and a specific risk management system explained.
This seminar 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 seminar also covers the application of risk management principles to complaint investigation
Day 1 Schedule
Regulatory Overview: FDA, ISO 13485 (including 13485:2016)
Application of Definitions
The Value of "Non-complaints"
Complaint Triage and Handling
Contents of Complaint Form
Complaint Review and Trending
Implementation of Risk Management into Complaint Handling
Common Pitfalls and How to Overcome Them
Exercise: Complaint or Non-complaint?
Day 2 Schedule
Adverse Event Reporting
Regulatory Overview: FDA, MDD
Exercise: Reportability of Events
Recalls / Field Corrective Actions
Regulatory Overview: FDA, MEDDEV, Health Canada
Competent Authority Reportable Event
Corrections and Removals
Market Withdrawal and Stock Recovery
Roles and Responsibilities
Q&A - Conclusion
Director of Regulatory Affairs, Life-Tech, Inc
Jeff Kasoff, RAC, CMQ/OE, LBB is the Principal Consultant at Lean to Quality, LLC. He has more than 30 years of experience in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from start-up to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes.