Complaint Handling and Recall Management

Complaint Handling and Recall Management

Heidelberg, Germany

Course No 9075


This conference already took place.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail:


Richard M. Bonner, ECA, formerly with Eli Lilly, U.K
Dr Gerald Kindermann, F. Hoffmann-La Roche Ltd., Switzerland
Aidan Madden, FivePharma, Ireland
Edit Szöcs, EU GMP Inspector, National Institute of Pharmacy, Hungary


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.

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) 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.

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 and decision makers who want to improve the existing process. Other parts of the organisation who may be on the receiving-end of complaints will also find the course very informative as to what to do when receiving complaints, who to involve and why it is so important to treat all complaints in a timely manner.


Regulatory requirements for Complaint Handling and Recall
Guidelines, Regulations and Directives
Medical and non-medical complaints
Counterfeited medicinal products

Complaint Handling Session
The Handling of Complaints (Part 1)
Implementation in GMP-System
When do you need to involve the regulatory authorities?
Interface to Pharmacovigilance, and the role of the QPs
Incoming complaints, who receives them, who investigates and who approves communications and responses?
Sample handling and storage
What is a 3 day field alert (FDA requirement) and is this important in the EU?

The Handling of Complaints (Part 2)
Initial documentation
Software/ databases
Sample evaluation
Failure Investigation
Why complaints can be good !!

Quality Risk Management Session
The Basics of Quality Risk Management
Definitions and abbreviations
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

Recall Session
The Handling of Recalls
Implementation in the system
The recall process
Flow of information

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.

Workshop on Case Studies:
Quality Risk Management in Complaint Handling
and Recall Procedures

Workshop: When to recall or not to recall – that’s the question
The participants will work through a single hypothetical scenario. Working in small groups the participants will need to decide what action to take, what information is needed, who should be involved, and ultimately decide if a recall is required and if so to what level.

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