Customer Complaint Handling

Managing Product Quality Complaints is both a regulatory requirement and an opportunity to continuously improve product quality and prevent the reoccurrence of future complaints. Global regulatory agencies and Current Good Manufacturing Practices (cGMPs) require pharmaceutical companies to have written procedures; a process in place to receive, investigate, and respond to customer complaints and staff adequately trained to perform these actions.
This course describes customer complaints and how to manage them compliantly. It includes an overview of types of complaints, a risk assessment framework, executing an investigation, and complaint closure.

CEU Credits: 0.1
Course Code: ELM-259
Duration: 15 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: V1.0
Effective Date: 01/09/2024

Curriculum for this course

Course Introduction
What is a Customer Complaint
What You Will Learn
Quality
Adverse Event
Non-quality
Sources of Complaints
Roles and Responsibilities
Initiation
Risk Assessment
Investigation
Root Cause Analysis
Product Disposition
CAPA
Record Closure
Trending
Summary
What We Covered

Test Your Knowledge

Results

Revision History

Author

Jacqueline Herlihy

Principal Consultant

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