Christof Langer
OSConsulting
Referent:innen
Aidan Madden
FivePharma
Dr Franz Schönfeld
GMP Inspector
Alexandra Bauloye
Johnson & Johnson Innovative Medicine
With many practical examples
Zielgruppe
Staff from production and quality units who establish, manage and apply Quality Risk Management Systems.
Zielsetzung
This ECA training course focuses on the practical implementation of Quality Risk Management (QRM).
Participants will learn how to apply QRM approaches to increase efficiency while meeting regulatory expectations.
Background
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.
Background
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.
Programm
ICH Q 9 - Quality Risk Management: an Overview
- QRM in non-GxP industries
- QRM in pharma
- Historical GMP perspective
- ICH Q9: current revision
- QRM tools and techniques
The Inspector’s View
- Expectations
- Integration in the Pharmaceutical Quality System
- Examples for good and poor 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 QRM after an Incident
- Performing a sound risk assessment after an event
- Making appropriate, risk-based decisions
Design of an Event Handling System based QRM
- 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
Building a clear 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
- How AI could support QRM
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
Practical examples of QRM
- How to implement Quality Risk Management in a pharmaceutical Company
- Using ICH Q9 and other Norms (with takeaways for Pharma)
- Examples
Weitere Informationen
Venue
Barceló Sants Hotel
Plaça dels Països Catalans, s/n
08014 Barcelona, Spain
+34 (93) 503 53 00
sants@barcelo.com
Barceló Sants Hotel
Plaça dels Països Catalans, s/n
08014 Barcelona, Spain
+34 (93) 503 53 00
sants@barcelo.com
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Social Event
On 16 September you are cordially invited to a social event (city tour and Dinner). This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Fees
ECA Members EUR 1,890.-
APIC Members EUR 1,990.-
Non-ECA Members EUR 2,090.-
EU GMP Inspectorates EUR 1,045.- per delegate plus VAT
The conference fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
ECA Members EUR 1,890.-
APIC Members EUR 1,990.-
Non-ECA Members EUR 2,090.-
EU GMP Inspectorates EUR 1,045.- per delegate plus VAT
The conference fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
Presentations/Certificate
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts
Questions regarding content:
Mr Wolfgang Schmitt, +49 6221 84 44-39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Ms Julia Grimmer, +49 6221 84 44-44, julia.grimmer@concept-heidelberg.de
Questions regarding content:
Mr Wolfgang Schmitt, +49 6221 84 44-39, w.schmitt@concept-heidelberg.de
Questions regarding organisation:
Ms Julia Grimmer, +49 6221 84 44-44, julia.grimmer@concept-heidelberg.de
Datum & Uhrzeiten
Wed, 16 Sept 2026, 09:00–17:15 h
Thu, 17 Sept 2026, 08:15–15:30 h
Thu, 17 Sept 2026, 08:15–15:30 h
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
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Quality Assurance Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
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