Complaint Handling and Recall Management - Live Online Training
12/13 November 2025
Course No. 22037
Speakers
Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Dr Gerald Kindermann
GxP Consulting
Aidan Madden
FivePharma
Dr Rainer Gnibl
GMP Inspector
Dr Agnes Kis
Compliance Consultant, formerly F. Hoffmann La-Roche
Please note: All times mentioned are CET.
Objectives
During this Live Online Training, you will learn all relevant aspects to efficiently organise and improve your Complaint Handling and Recall System to fulfil current GMP requirements and to get the best benefit for your daily business.
Background
In principle, every complaint might cause a recall, and every complaint may provide an opportunity to improve.
According to the EU-GMP Guide Chapter 8, the pharmaceutical industry must review all complaints and other information concerning potentially defective products carefully according to written procedures. In order to provide for all contingencies, a system should be designed to investigate the need to recall, if necessary, promptly and effectively products known or suspected to be adulterated from the market-place.
According to the EU- GMP Guide, a person should be designated responsible for handling the complaints and deciding the measures to be taken. The Qualified Person (QP) together with the Qualified Person for Pharmacovigilance (QPPV) should be made aware of any complaint, and be actively involved in the investigation and any subsequent recall.
The handling of technical complaints (also called non-medical complaints) triggers high demands on the process organisation and quality system. However, these complaints are also a chance for continuous improvement and to prevent the reoccurrence of future failures.
Reviewing FDA’s Warning Letters of the last fiscal years reveals that Complaint Handling processes are a hot topic. Recent media coverage of recalls due to non-GMP operations and counterfeit products entering the supply chain are also an indication of how important it is to treat all complaints with the highest priority. The main failures can be found in the overall process and in inadequate investigations, as the following excerpts show:
“Your firm failed to follow procedures for the handling of all written and oral complaints”
“he inadequacy of your firm’s quality oversight is demonstrated by the failure to perform thorough investigations of product failures and complaints.”
“The QCU failed to ensure customer complaints were adequately investigated”
“Your firm failed to review and approve complaints”
Target Group
This Live Online Training is designed for all personnel involved in complaint handling and/ or recall activities at their company and all responsible persons like the Qualified Person / the Qualified Person for Pharmacovigilance (QPPV) and decision makers who want to improve the existing process.
Technical Requirements
Date of the Live Online Training Wednesday, 12 November 2025, 9.00 – 17.30 h (CET) Thursday, 13 November 2025, 9.00 – approx. 13.00 h (CET)
Technical Requirements
We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/onlinetraining-technical-information you will find all the Information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a Standard nowadays and the necessary installation is fast and easy.
How to handle Complaints - Complaint Management Process
Regulations (EU, US FDA)
How to organize the process
The complaint sample and sample chain custody
Complaint investigation: Examples
Pitfalls
Regulatory Requirements for Complaint Handling and Recalls - The Inspector’s View
EU Legislation on Complaints, Recalls & Falsification
Real Intension of Complaint Handling
Definition and Classification of Quality Defects
Rapid Alert System - RAS
What a Complaint Handling SOP should consider
What a Recall SOP should consider
How to handle Complaints - Complaint Management Quality System
Quality Metrics & KPIs
Reporting and trend evaluation
Technical complaints versus safety signals
The role of the QP and QPPV
Effectiveness of PQS
Q & A Session 1
Quality Risk Management Session
The Basics of Quality Risk Management
Definitions and abbreviations
Fundamentals
Regulatory requirements and expectations
Areas of application
Construction of a QRM matrix
Implementation of a Quality Risk Management System in Complaint Handling
How to use real data from global issues to determine process understanding and customer satisfaction and to set priorities.
Case Study: Quality Risk Management in Complaint Handling and Recall Procedures
Q & A Session 2
Programme Day 2
Recall Session
The Handling of Recalls
Implementation in the system
The recall process
Flow of information
Documentation
How to perform a Mock Recall
Both FDA and EU GMPs call for regular evaluations of the effectiveness of the recall processes. This session will show you, how such an effectiveness check could be performed.
A practical View: Access to the Root Cause
When to Recall or not to Recall – Apply Root Cause Analysis A hypothetical scenario will be shown: What action needs to be taken, what information is needed, who should be involved, and ultimately - Is a recall required and if so to what level?
Q & A Session 3
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager" Learn more
Testimonials
Seminar Programme as PDF