Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Referierende
Dr Gerald Kindermann
GxP Consulting
Aidan Madden
FivePharma
Dr Rainer Gnibl
GMP Inspector
Dr Agnes Kis
Compliance Consultant, formerly F. Hoffmann La-Roche
Facing the GMP- GVP interface: The role of the QP and the QPPV
Highlights
Regulatory requirements
Failure Investigation
Decision Making Process
Zielgruppe
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.
Zielsetzung
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.
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. 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.
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 Intention 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 Requirements
Our live online training courses and webinars are conducted using Webex. At www.gmp-compliance.org/training/online-training-technical-information you will find all necessary information for participation, including a system check to verify whether your IT environment meets the technical requirements. If the installation of browser extensions is restricted due to internal IT policies, please contact your IT department. Webex is widely used, and installation is straightforward.
Fees (per delegate, plus VAT)
ECA Members 1.890 EUR
APIC Members 1.990 EUR
Non-ECA Members 2.090 EUR
EU GMP Inspectorates 1.045 EUR
The conference fee is payable in advance upon receipt of invoice.
ECA Members 1.890 EUR
APIC Members 1.990 EUR
Non-ECA Members 2.090 EUR
EU GMP Inspectorates 1.045 EUR
The conference fee is payable in advance upon receipt of invoice.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
The official conference language will be English.
You cannot attend the Live Event?
Many of the training courses and conferences are also available as recordings. You may watch these any time “on demand” on our web server. It is uncomplicated and doesn’t require any software – you simply watch the videos in your browser. All available recorded events can be found at www.gmp-compliance.org/recordings.
Many of the training courses and conferences are also available as recordings. You may watch these any time “on demand” on our web server. It is uncomplicated and doesn’t require any software – you simply watch the videos in your browser. All available recorded events can be found at www.gmp-compliance.org/recordings.
Contacts
Questions regarding content:
Dr Andrea Kühn-Hebecker, +49 6221 84 44-35, kuehn@concept-heidelberg.de
Questions regarding Organisation:
Marion Grimm, +49 6221 84 44-18, marion.grimm@concept-heidelberg.de
Questions regarding content:
Dr Andrea Kühn-Hebecker, +49 6221 84 44-35, kuehn@concept-heidelberg.de
Questions regarding Organisation:
Marion Grimm, +49 6221 84 44-18, marion.grimm@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 1 Dec 2026, 9:00-17:30
Wed, 2 Dec 2026, 9:00-13:00
Wed, 2 Dec 2026, 9:00-13:00
All times mentioned are CET.
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager"
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Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
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