Christof Langer
OSConsulting
Referent:innen
Aidan Madden
FivePharma
Dr Franz Schönfeld
GMP Inspektor
Alexandra Bauloye
Johnson & Johnson Innovative Medicine
Zielsetzung
This ECA training course deals with the practical implementation of Quality Risk Management (QRM). You will learn how to implement and use QRM approaches to increase efficiency and to meet the expectations of the regulators.
Hintergrund
The ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the marketing authorisation holder (MAH). To achieve the quality objective, “there must be a comprehensively designed and correctly implemented system of Quality Assurance incorporating Good Manufacturing Practice, Quality Control and Quality Risk Management.” [EU-GMP Guidelines, Part 1, Chapter 1].
QRM was formally introduced to the pharmaceutical industry with the ICH Q9 Guideline, which has been incorporated in the EU-GMP Guidelines, Part 3. In the course of implementing ICH Q9, risk-based approaches increasingly gained in importance. Before that, it was often the case that processes were defined, implemented and documented to the latest detail. Now, based on risk assessments, more flexibility is possible, allowing implementing and controlling processes more efficiently. Decisions can be made based on evaluated risks. Unfortunately, many companies limit their whole QRM system to the implementation of the FMEA method only. But it is much more than this and QRM can support the pharmaceutical industry in improving their processes and performance.
QRM was formally introduced to the pharmaceutical industry with the ICH Q9 Guideline, which has been incorporated in the EU-GMP Guidelines, Part 3. In the course of implementing ICH Q9, risk-based approaches increasingly gained in importance. Before that, it was often the case that processes were defined, implemented and documented to the latest detail. Now, based on risk assessments, more flexibility is possible, allowing implementing and controlling processes more efficiently. Decisions can be made based on evaluated risks. Unfortunately, many companies limit their whole QRM system to the implementation of the FMEA method only. But it is much more than this and QRM can support the pharmaceutical industry in improving their processes and performance.
Zielgruppe
This training course is designed for members of staff in pharmaceutical, biopharmaceutical and API industry’s production and quality units, who establish, manage and use quality risk management systems.
Date & Venue
Date
Wednesday, 03 September 2025, 09.00 – 17.15 h
(Registration and coffee 08.30 – 09.00 h)
Thursday, 04 September 2025, 08.15 - 15.30 h
Wednesday, 03 September 2025, 09.00 – 17.15 h
(Registration and coffee 08.30 – 09.00 h)
Thursday, 04 September 2025, 08.15 - 15.30 h
Venue
Barceló Hotel Hamburg
Ferdinandstraße 15, 20095 Hamburg, Germany
Tel. +49 (0) 40/22 63 62 0
Fax +49 (0) 40/22 63 62 999
E-mail: hamburg@barcelo.com
Programm
Gesamtes Programm als PDF herunterladen
ICH Q 9 - Quality Risk Management: an Overview
- QRM in non-GxP industries
- QRM in pharma
- Historical GMP Situation
- ICH Q9: current Revision
- QRM tools and techniques
The Inspector’s View
- Expectations
- Integration in the Pharmaceutical Quality System
- Examples for good and not so good practice
How to realise Quality Risk Management in a GMP Environment
- The term "quality risk management" is used throughout the GMP guidelines. In this session you will get some practical advice on how implement QRM
- SOPs needed
- Auditing
Interactive Session: Applying Principles of QMR after an Incident has happened
A problem has occurred – how to perform a sound Risk Assessment of the situation and come to an appropriate decision.
A problem has occurred – how to perform a sound Risk Assessment of the situation and come to an appropriate decision.
Design of an Event Handling System based on a Quality System and Quality Risk Management Approach
- QRM in the Quality System
- Design of an Event Handling system based on QRM and Management Review
- Use of QRM in the evaluation of Events
- Examples
Build a good Risk Description/ Statement: Bow Tie Method
- Distinguish causes and consequences
- What is the difference between hazard and Risk
- Use the bow tie method to categorise the pieces of the puzzle and get a clear risk statement
Case Study: Quality Risk Register
- What is it, how to develop it and which type of risks to include
- What to show to authorities?
- The way to business continuity
- Examples
QRM Tools in Practice
- How to implement Quality Risk Management in a Pharmaceutical Company
- Using ICH Q9 and other Norms (with takeaways for Pharma)
- Examples
| 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
Aufzeichnung 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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