Learning Material


Preparing yourself for the EuBIS course - The 10 Essentials to understand for Seminar and training ("The risk based approach - from the design to the implementation of the quality system")

The EuBIS Academy aims to give training to a broad variety of Individuals and experts in the field of transfusion medicine. The course does integrate a seminar and practical work to give the possibility of interactive learning.

The training programme is based on the EuBIS Manual and Inspection/Audit Training Guide (given as e-books on this home page or available as pdf-downloads on request). Independent from the level of expertise of the trainees, the EuBIS academy members would like to give the following 10-Essential information to those trainees attending the course, in order to prepare themself and/or to reconfirm on their expertise.

In order to prepare yourself for the course, please read the following chapters:

EuBIS Manual
Chapter 5 - Self-Inspection of blood establishments Site-master-File for blood establishments (also refer to Annex I)
5.3 Integration of quality risk management into self-inspection (also refer to EudraLex, Volume 4, Annex 20)
6.4 Planning for and assessment of an inspection
Chapter 7 - conduct of an inspection
Definitions for non-compliances (page 25, page 77 and Annex V, page 106)

EuBIS Inspection/Audit Training Guide
Chapter 3.3 Premises
3.3.1. Blood donor and collection area
3.3.2 Blood testing and processing area
Chapter 3.5 Blood collection, testing and processing
3.5.1 Donor eligibility
3.5.2 Collection of blood and blood components
3.5.3 Laboratory testing
3.5.4 Processing and validation
3.5.5 Labelling
3.5.6 Release of blood and blood components

Please refer also to the 10-Essentials listed below and the documents (PDF) enclosed, that can be downloaded:

Essential 1 - EuBIS Manual (Inspection / Quality Requirements)
Essential 2 - EuBISAudit/Inspection Training Guide (Quality Management and Critical Sub-Processes)
Essential 3 - assisting EuBIS Documents
Essential 4 - Directive on Quality Management and related Blood Directives
Essential 5 - Blood Components are different from Blood Stem Cells
Essential 6 - CoE (EDQM) Guide for 'Quality and Safety' of Blood
Essential 7 - Pharmaceutical Inspection Convention / Co-Operation Scheme (PIC/S)
Essential 8 - GMP (Eudralex) Quality Management and Risk Assessment
Essential 9 - Good Practice Guidelines (GPG) for Blood Establishments and Hospital Blood Banks
Essential 10 - GMP_Part III_ICH guideline_Q9 risk management and Q10 pharmaceutical quality system
Further references - The EUROGTP guides
Further references - Vistart Inspection Guidelines