2018 - Complaint Management: Best Practices to Assure Compliance and Customer Retention

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!
WHY SHOULD YOU ATTEND
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. Also covered will be the application of risk management to a complaint handling system, and a specific risk management system explained.
AREAS COVERED
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
LEARNING OBJECTIVES
This training will detail how you can handle customer complaints in compliance with FDA and ISO regulations. The instructor will discuss topics like best practices for documenting customer feedback, what constitutes a complaint, what to do with non-complaint feedback, and how to include complaint trending into your firm’s CAPA program.
WHO WILL BENEFIT
Customer Service (your “complaint taker”)
Regulatory personnel
Quality Engineering personnel
Sales and Marketing personnel
Customer Service personnel
R&D personnel
Manufacturing Engineering
Executive Management
Consultants
Quality system auditors
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