Complaint Handling and Recall Management

Complaint Handling and Recall Management

Heidelberg, Germany

Course No 15623


Costs

Non-ECA Members: EUR 1690,--
ECA Members: EUR 1490,--
EU GMP Inspectorates: EUR 845,--
APIC Members (does not include ECA membership): EUR 1590,--

(All prices excl. VAT)

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

Speakers

Richard M. Bonner, ECA, formerly with Eli Lilly, U.K

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

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

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 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

The Handling of Complaints (Part 1)
  • Implementation into the 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 !!
Case Study:
Effective Root Cause Analysis and Failure Investigation

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.

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