Complaint Handling and Recall Management

18-19 September 2018

Hamburg, Germany

Course No 16239

Our Service

Costs

This conference already took place.

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

Speakers

Dr Rainer Gnibl, GMP-Inspector for EMA and local Government, Germany

Dr Gerald Kindermann, F. Hoffmann-La Roche Ltd., Switzerland

Dr Ágnes Kis, Compliance Consultant, formerly with F. Hoffmann La-Roche Ltd, Switzerland

Dr Ulrich Kissel, European QP Association, KisselPharmaConsulting, Germany

Aidan Madden, FivePharma, Ireland

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.

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) 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 / the Qualified Person for Pharmacovigilance (QPPV) and decision makers who want to improve the existing process.

Programme

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.

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.

Go back