Complaint Handling and Recall Management - Live Online Training

19/20 November 2024

Course No. 21364

header-image

Speakers

Dr Ulrich Kissel

Dr Ulrich Kissel

European QP Association (EQPA), KisselPharmaConsulting

Aidan Madden

Aidan Madden

FivePharma

Dr Rainer Gnibl

Dr Rainer Gnibl

GMP Inspector

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.

Objectives

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.

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) 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”

Target Group

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.

Programme

Complaint Handling and Recall Management - Live Online Training

Seminar Programme as PDF

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

stop

This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager" Learn more

This training/webinar cannot be booked. Send us your inquiry by using the following contact form.

To find alternative dates for this training/webinar or similar events please see the complete list of all events.

For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.

* also payable by credit card
American Express Visa Mastercard

icon
Further dates on-site
Further dates on-site
Not available
icon
Further dates online
Further dates online
Not available
icon
Recording
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

Woman with headset

Go back

Testimonials about our courses and conferences

"Great material and speakers" and "Great speakers a lot of experience and sharing"

Felipe Gonzalez, Mucos Emulsionsgesellschaft mbH
Live Online Training - Granulation & Tableting, September 2024

"The lectures were very informative, interesting and entertaining."

Albert Godoy Hernández, Company synaffix
Live Online Training - GMP Auditor Practice, October 2024

"Really useful training which I will use in my daily work."

Regina Mommaerts, Galapagos NV
Live Online Training - GMP Auditor Practice, October 2024

"Wonderful format of the sessions: Good range of participations and experience in the team. Would love to attend another one soon."

Roopasi Mathi, Wacker Biotech B.V.
Live Online Training - GMP Auditor Practice, October 2024

"Very good balance between general and detailed information"

Dr Ralf Albrecht, Tillotts Pharma AG
Live Online Training - Granulation & Tableting
September 2024

"Nice presentations: easy understanding, quite visual"

Susana Manrique, Boehringer Ingelheim España, S.A,
Live Online Training - Granulation & Tableting, September 2024

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023