Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Referent:innen
Aidan Madden
FivePharma
Dr Rainer Gnibl
GMP Inspector
Dr Gerald Kindermann
GxP Consulting
Dr Agnes Kis
Compliance Consultant, formerly F. Hoffmann La-Roche
Zielgruppe
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.
Zielsetzung
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
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:
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”
Programm
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?
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
Weitere Informationen
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your Needs. In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.
Contacts
Questions regarding Content:
Dr Andrea Kühn-Hebecker, +49 (0)6221 8444 35, kuehn@concept-heidelberg.de
Questions regarding organisation:
Mr Maximillian Bauer, +49 (0) 6221 84 44 25, bauer@concept-heidelrberg.de
Recording from 12/13 November 2025
Duration of Recording: 8h 16min
Duration of Recording: 8h 16min
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Regular Fee*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager"
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E-Mail: info@concept-heidelberg.de
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