Alexandra Bauloye, GSK Belgium
Christof Langer, OSConsulting, Austria
Aidan Madden, FivePharma, Ireland
Dr Franz Schönfeld, GMP Inspector, Germany
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.
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.
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.
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
- 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:
- Chapter 1
- Chapter 2
- Annex 1
- Annex 15
- Annex 16
- SOPs needed
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.
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
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
How to implement Quality Risk Management in a pharmaceutical Company
- Part 1: QRM Tools made practicable in daily life
- ICH Q9 and other Norms (with takeaways for Pharma)
- Strength of practical DMAIC methodology
- QRM culture: principles and examples
- Cost of Quality/Compliance
- Part 2: Examples
- Change Control