Complaint Handling and Recall Management - Live Online Training

19/20 November 2024

Seminar-Nr. 21364


Dr. Ulrich Kissel

Dr. Ulrich Kissel

European QP Association (EQPA), KisselPharmaConsulting

Aidan Madden

Aidan Madden


Dr. Rainer Gnibl

Dr. Rainer Gnibl

GMP Inspektor, Regierung von Oberbayern

Dr Gerald Kindermann

Dr Gerald Kindermann

GxP Consulting

Dr Agnes Kis

Dr Agnes Kis

Compliance Consultant, formerly F. Hoffmann La-Roche

Please note: All times mentioned are CET.


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.


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”


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

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.


Complaint Handling and Recall Management - Live Online Training

Gesamtes Programm als PDF herunterladen

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 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

ECA-Member*: € 1690,-
Non ECA Member*: € 1890,-
EU/GMP Inspectorates*: € 945,-
APIC Member Discount*: € 1790,-

Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.

* auch unkompliziert per Kreditkarte bezahlbar
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Teilnehmerstimmen - das sagen andere über unsere Seminare:

"Die Umsetzung mit Memberspot ist wirklich ausgezeichnet gelungen.
Es unterstützt die Wissensvermittlung und gewährleistet auch die richtige Durchführung des Kurses.”
Christian Wagener, WAGENER & CO. GmbH
GMP Basis-Einstiegsschulung (B 1) - Aufzeichnung Online Seminar, April 2024

Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis,
welche die Theorie super veranschaulicht.”
Marina Kicoranovic, Labor Hartmann GmbH
GMP/Basis-Einstiegsschulung (B 14), September 2023

Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe
verwendet (super) und waren sehr praxisbezogen.”
Astrid Gießler, Regierungspräsidium Karlsruhe
Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023

Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.”
Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG
GMP-Basisschulung (B 1), Juni 2023

„Interessante Themen, gut vorgetragen, die eigenen Erfahrungen der Vortragenden helfen, dies noch besser nachzuvollziehen.“ „Gute Gestaltung der Workshops, das Zusammenarbeiten in Gruppen und der Austausch mit anderen hilft sehr.“
Manuela Seibert, Merck, GMP-Leadauditor/in (FA 2), April 2024


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