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: 09/01/2024

Curriculum for this course

Course Introduction
34 secs
What is a Customer Complaint
4 secs
What You Will Learn
8 secs
Quality
20 secs
Adverse Event
28 secs
Non-quality
24 secs
Sources of Complaints
26 secs
Roles and Responsibilities
28 secs
Initiation
52 secs
Risk Assessment
44 secs
Investigation
32 secs
Root Cause Analysis
1 min 31 secs
Product Disposition
47 secs
CAPA
55 secs
Record Closure
23 secs
Trending
35 secs
Summary
24 secs
What We Covered
18 secs

Test Your Knowledge

Results

Revision History

Author

Jacqueline Herlihy

Principal Consultant

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