Complaint Handling and Recall Management

Complaint Handling and Recall Management

Heidelberg, Germany

Course No 17566



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Dr Rainer Gnibl,  GMP Inspector for EMA and Local Government, Germany
Aidan Madden, FivePharma, Ireland
Dr Gerald Kindermann, formerly F. Hoffmann-La Roche, Switzerland
Dr Ágnes Kis, Compliance Consultant, formerly F. Hoffmann La-Roche, Switzerland
Dr Ulrich Kissel, European QP Association, KisselPharmaConsulting, Germany


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.

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”
  •  “The 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 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.


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
Complaint Handling Session
How to handle complaints - complaint management process
  •  Regulations
  •  How to organize the process
  •  The complaint sample and sample chain custody
  •  Pitfalls
How to handle complaints - complaint management quality system
  •  KPIs
  •  Reporting and trend evaluation
  •  Technical complaints versus safety signals
  •  The role of the QP and QPPV
  •  Counterfeits
A practical view:
  • Share experience - access to the root cause
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.
Workshop on Case Studies:
  • Quality Risk Management in Complaint Handling and Recall Procedures
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.
When to recall or not to recall – apply root cause analysis

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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