Complaint Handling and Recall Management - Live Online Training
How to implement EU-GMP Chapter 8
1/2 December 2026
Course No. 22516
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
Facing the GMP- GVP interface: The role of the QP and the QPPV
Highlights
Regulatory requirements Failure Investigation Decision Making Process
Target Group
This course 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.
Objectives
During this course, 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.
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. 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.
Programme
Programme Day 1
Complaint Handling Session
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 Intention 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
Further Information
Technical Requirements
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Fees (per delegate, plus VAT) ECA Members 1.890 EUR APIC Members 1.990 EUR Non-ECA Members 2.090 EUR EU GMP Inspectorates 1.045 EUR The conference fee is payable in advance upon receipt of invoice.
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
You cannot attend the Live Event? Many of the training courses and conferences are also available as recordings. You may watch these any time “on demand” on our web server. It is uncomplicated and doesn’t require any software – you simply watch the videos in your browser. All available recorded events can be found at www.gmp-compliance.org/recordings.
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