Effective Pharmaceutical Product Complaints Handling, Investigations & CAPA

Ranjit Barshikar

Course description

This will equip you with an overview of the rules and regulations governing complaint handling and documentation within the pharmaceutical and related industries.

In compliance with 21 CFR Parts 210 and 211, manufacturers are required to maintain a complaint log or register, establish a complaint handling and CAPA (Corrective and Preventive Action) system, and implement SOPs (Standard Operating Procedures) for receiving, reviewing, and evaluating complaints. This process must involve key departments to ensure thoroughness.

While minimizing product complaints is a goal, an effective complaint handling procedure is essential
for continuously improving the Quality System.

Upon completion of this course, you will be able to:

• Define the process and management of a complaint investigation as per 21 CFR Part 210 & 211.
• List various types of complaint classifications and benefits of filing a complaint.
• Explain the steps of Complaint Processing at a Manufacturing Unit.
• Analyze, approve, and take corrective actions based on the results of a complaint investigation.
• Evaluate the effectiveness of CAPA (Corrective & Preventive Actions).
• Summarize FDA’s expectations as it applies to Complaint Handling.
• Review previous FDA‐483 Observations and Warning Letter Citations Related to Complaints.
• Evaluate the content of a Complaint Handling and Investigation Standard Operating Procedure with an example of a complaint investigation report.

COURSE OUTLINE:

Module 1:

• Regulatory Guidelines and Initial Consideration of a Complaint Process
• Understanding Complaints / Corrective actions / Preventive actions
• Benefits of Filing Complaints
• Classifications of Complaints

Module 2

• Stepwise handling of Complaints Process for Investigations & CAPA
• Ensuring the effectiveness of CAPA
• Approving Product Complaint Investigation
• Feedback to Customers on CAPA
• Management responsibilities
• Documentation

Module 3

• Understanding Risk-based approach to complaints handling
• Trending and FDA 483 / Warning letters
• Case Studies