Training Course Syllabus:

Overview:

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.

Learning Objectives:

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

Agenda:

Day 1 Schedule

Lecture 1:
Introduction

Lecture 2:
Complaint Handling

Regulatory Overview: FDA, ISO 13485 (including 13485:2016)
Definitions
Application of Definitions
The Value of "Non-complaints"
Complaint Triage and Handling
Complaint Investigations
"Closing" Complaints
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

Lecture 1:
Adverse Event Reporting

Regulatory Overview: FDA, MDD
MDRs
Reporting Process
Reporting Requirements
Vigilance Reports
Reporting Process
Reporting Requirements
Exercise: Reportability of Events
Lecture 2:
Recalls / Field Corrective Actions

Regulatory Overview: FDA, MEDDEV, Health Canada
FDA Regulations
EU Requirements
Competent Authority Reportable Event
Reporting Requirements
Corrections and Removals
Market Withdrawal and Stock Recovery
Recall Classifications
Roles and Responsibilities
Lecture 3:
Q&A - Conclusion

Speaker:

Jeff Kasoff
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.

Seminar Summary:

 (see full course description)

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