Registration is closed for this training course. Accepted participants will be notified by email.
From blood collection, testing and processing to release and distribution, there are many steps involved in the supply of blood components and each carries intrinsic and extrinsic risks. These risks can only be mitigated if they are proactively identified and controlled throughout the blood supply lifecycle and this is achieved by incorporating the principles of Quality Risk Management (QRM) into the Quality Management System (QMS) in accordance with EU blood legislation and the Good Practice Guidelines.
A risk-based QMS thus remains key to ensure the efficacy, quality and safety of blood components while striving for cost-effectiveness.
The concept of QM in the field of blood transfusion has greatly evolved over the last decade and Blood Establishments have had to continuously adapt to new regulatory and technical requirements. In this context, QRM can play a pivotal role to implement requirements to the extent it is required.
The EDQM/Council of Europe plays a central role in the field of blood for human application by facilitating the exchange of knowledge and promoting the harmonisation of practices across Europe and beyond. It captures changes in the field in regular updates to the Guide to the preparation, use and quality assurance of blood components. As part of this role the EDQM/Council of Europe will be organising a training course on QRM in the field of blood.
The aim of this training course is to support blood establishments in implementing and further developing a robust, risk-based QMS.
The training will cover the fundamental aspects of QRM and equip participants with the knowledge, skills and tools necessary to integrate QRM into the core, support and continuous processes of a QMS, such as processing activities, change control and non-conformance/CAPA management.
Key topics that will be covered in the training course:
- principles of QRM, tools and steps to implement it in practice,
- identifying risks in processes,
- application of QRM to non-conformance/CAPA management,
- application of QRM to change control,
- application of QRM to qualification/validation,
- case studies covering identification, control and mitigation of risks in day-to-day activities.
Dates and format
The training will be delivered in five modules over 5 weeks, as follows:
Self-training during the first 4 weeks:
- Pre-learning material and exercises will be supplied at the beginning of each week (on 2, 8, 15 and 22 November). Participants will have a week to complete each module.
- During this period, participants will have the opportunity to provide their feedback to the Training Team.
Live online sessions on 2 days:
- On 29 and 30 November, participants will have the opportunity to further practice the knowledge and skills acquired during the first four modules, benefit from advanced live presentations and case studies, and interact with experienced QRM experts.
- 29 and 30 November from 9:00 a.m. to 12:00 p.m. and 2:00 p.m. to 5:00 p.m.
Who should apply & eligibility
This training course will be of interest to Blood Establishment personnel in charge of QM, change control, risk management, NC/CAPA management and/or processing activities.
Before applying, please check that you meet the following essential eligibility criteria:
- Resident in a Council of Europe member state
- Employed in a Blood Establishment
- Good knowledge of English