Charisma

#	Content
1	Module 1: Introduction to Product Quality Complaints
2	Module 2: Complaint Management Process
3	Module 3: Investigation of Product Quality Complaints
4	Module 4: Root Cause Analysis
5	Module 5: Corrective and Preventive Actions (CAPA)
6	Module 6: Documentation and Reporting
7	Module 7: Trending and Continuous Improvement
8	Module 8: Case Studies and Practical Exercises

#	Outcomes
	• Define product quality complaints and their significance in quality management systems.
	• Classify and evaluate product complaints according to risk and severity.
	• Conduct complaint investigations using systematic approaches.
	• Prepare complaint reports and maintain compliant documentation.
	• Identify root causes using quality tools and methodologies.
	• Recommend and implement CAPA plans.
	• Monitor complaint trends and utilize data for continual improvement.
	• Demonstrate compliance with GMP and relevant regulatory expectations.

#	Participants
1	� • Quality Assurance (QA) professionals.
2	� • Quality Control (QC) personnel.
3	� • Production and Manufacturing staff.
4	� • Regulatory Affairs professionals.
5	� • Warehouse and Distribution personnel.
6	� • Pharmacovigilance staff.
7	� • Pharmaceutical and medical device industry employees.
8	� • GMP auditors and compliance specialists.
9	S Supervisors and managers involved in quality systems.