EuBIS
European Blood Inspection System
Initiated under the Public Health Programme of the EC
Directorate General SANCO - GA No. 2006202
5th International EuBIS Seminar and Training
Quality management and inspection criteria
for blood establishments
14th – 17th of October 2014, Istanbul, Turkey
From ‘good to best practice’
Organised by the EuBIS Academy
in association with the Turkish Red Crescent and PIC/S
under the auspices of the Ministry of Health
supported by the
Trainee Programme – 2 Announcement
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EuBIS
European Blood Inspection System
Initiated under the Public Health Programme of the EC – GA No. 2006202
5th International Seminar and Training Course – Istanbul, 14th - 17th of October 2014
Invitation
Dear colleagues,
the EuBIS Project, initiated under the Public Health Programme of the European Commission,
Directorate General SANCO, has developed a manual and a guide containing standards and guidelines
for quality management and the inspection of blood establishments. Based on the EuBIS manual and
guide the EuBIS Academy has organised training seminars and courses in order to promote knowledge
in the area of quality and safety of blood and blood components throughout Europe and world wide.
Following the 1st International seminar during the ISBT congress in Berlin, Germany, the 2nd , 3rd and
4th International Seminar and Training Course have been organised in cooperation with the Centro
Nazionale Sangue in Rome (Italy, 2011), the Belgium Red Cross Flanders in Leuven (Belgium, 2012) and
the Irish Blood Transfusion Service (Dublin, 2013), the training has received extensive international
reputation with participants from EU member states (Austria, Belgium, Bulgaria, Croatia, Cyprus,
Czech Republic, Denmark, Estonia, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Malta,
The Netherlands, Poland, Portugal, Romania, Spain, Sweden, United Kingdom) and world-wide
(Norway, Switzerland, Turkey, Brazil, Curacao, Morocco, Macedonia, Nigeria, Singapore, Saudi Arabia,
South Africa, South Korea, United State of America).
The 5thEuBIS International Seminar and Training Course is organised by the EuBIS Academy in
association with the Turkish Red Crescent Organisation and the Pharmaceutical Inspection Cooperation Scheme (PIC/S) under the auspices of the Turkish Ministry of Health and will be a further
milestone in the objectives of EuBIS to give assistance in promoting it’s mission ‘from good to best
practice’.
On behalf of all EuBIS Project participants, Collaborating partners and the Academy trainers, we are
looking forward to welcome you in Istanbul, Turkey and hope that we will have an exciting training
including fruitful discussions and extensive exchange of ideas.
Prof. Dr. Christian Seidl
Dr. Fewzi Teskrat
Uzm. Dr. Nigar Ertugrul Oruc
EuBIS Academy Coordinator
Former Co-Chair of PICS
Expert Circle on Blood, Tissues and Cells
Blood Bank Manager
Turkish Ministry of Health
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EuBIS
European Blood Inspection System
Initiated under the Public Health Programme of the EC – GA No. 2006202
5th International Seminar and Training Course – Istanbul, 14th - 17th of October 2014
Publication notice:
EuBIS inspection manual and guide
The training is performed based on the EuBIS manual and EuBIS Guide developed under the Public
Health Programme co-funded by the European Commission, Health and Consumer Protection
Directorate General, Public Health and Risk Assessment Directorate, DG Sanco Grant Agreement No.
2006202. (2003-2008)
The manual and guide comprise common standards and criteria for the inspection of blood
establishments and have been developed based on the European blood legislation and cross
referenced to GMP, EDQM and PIC/S standards.
Further information on this manual including updated versions is available from the project Website of
EUBIS (European blood inspection system) (www.EUBIS-europe.eu).
Supported by the European Blood Alliance (EBA)
The
EuBIS Inspection Standards and Criteria
EuBIS Inspection Training Guide
Educational Material
are the final versions developed by the EuBIS Project (Copyright ®).
CATIE facilitator manual
For the educational material of this course the European Commission has given the permission to use
the CATIE Facilitator manual developed by the CATIE consortium under the contract No. 2011/S 16727519 of the Executive Agency for Health and Consumers (EAHC) and the Directorate General Sanco
(GD Sanco).
The use of this material has been granted for this training course performed under the ‘Project for
Technical Assistance for strengthening the blood supply system in Turkey’ by the European
Commission.
Disclaimer:
The content of the manual, guide or the educational material does not necessarily reflect the views of
the European Commission. Neither the Commission nor any person acting on its behalf can be held
responsible for any use that may be made of the information in this report.
Neither the EuBIS Academy members nor the European Commission assume any responsibility for the
use that may be made of the information in the manual and training material.
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EuBIS
European Blood Inspection System
Initiated under the Public Health Programme of the EC – GA No. 2006202
5th International Seminar and Training Course – Istanbul, 14th - 17th of October 2014
EuBIS Academy Members:
Dr. Fewzi Teskrat, ANSM, France
Dr. Alex Aquilina, MBTS, Malta
Mr. Jan Ceulemans, HBRC-RKV, Belgium
Dr. Jose Manuel Cardenas, CVTB, Spain
Prof. Dr. Giuliano Grazzini, CNS, Italy
Dr. Simonetta Pupella, CNS, Italy
Dr. Jan Peter Jansen van Galen, emer. Sanquin, NL
Dr. Gwen Mast, Sanquin, The Netherlands
Dr. Margarethe Heiden, PEI, Germany
Dr. Helga Marie Huber, PEI, Germany
Wiebke Siegel, GMP-Insp. Germany
Mr. Mark Nightingale, NHSBT, United Kingdom
Prof. Dr. Christian Seidl, BSDBH, Germany
Dr. Jeroen de Wit, Sanquin, The Netherlands
Prof. Dr. Philippe Vandekerckhove, EBA, Belgium
Uzm. Dr. Nigar Ertugul Oruc, Diskapi YBTRH, Turkey
Organisers:
Prof. Dr. Christian Seidl, EuBIS coordination office
Prof. Dr. Dr. h. c. Erhard Seifried, BSDBH
Uzm. Dr. Nigar Ertugrul Oruc, Diskapi YBTRH, Ministry of Health Turkey
Affiliates:
Dr. Gilles Folléa, Executive Director, European Blood Alliance
Dr. Fewzi Teskrat, Chair PIC/S Expert Circle on Blood, Tissues and Cells
Meeting Venue:
Kalyon Hotel Istanbul
Kennedy Caddesi no 34
Sultanahmet 34122
Istanbul/ Turkey
Tel: (90-212) 517 44 00 Fax: (90-212) 638 11 11
EuBIS Emergency mobile: +49 174 33 77 088
Course language:
Registration Fee:
Joint Academy Dinner:
English
470,- Euro
55,- Euro (optional)
For registration please refer to the EuBIS Coordination Office
Mrs. Tanja Knoth
DRK-Blutspendedienst Baden-Württemberg-Hessen
Sandhofstrasse 1
60528 Frankfurt am Main
Tel.: +49-69-6782-444 / Fax.: +49-69-6782-254 e-mail: [email protected]
Course Information: www.eubis-europe.eu (application forms)
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EuBIS
European Blood Inspection System
Initiated under the Public Health Programme of the EC – GA No. 2006202
5th International Seminar and Training Course – Istanbul, 14th - 17th of October 2014
Tuesday, the 14th of October 2014
10:30-11:15
Opening and Welcome
Officials, tba
Introduction of the trainers and the participants
Prof. Dr. Christian Seidl
‘Break the Ice’
Dr. Fewzi Teskrat and Uzm.Dr. Nigar Ertugul Oruc
11:15-12:00
Seminar I – Quality management and inspections
EuBIS Manual and Training Guide
11:15-12:00
(Lecture 1) Common regulatory requirements and essential quality standards
(EuBIS manual and guide)
Prof. Dr. Christian Seidl
12:00-12:30
(Lecture 2) Regulations for codification, import and expert of human substances
(tba)
12:30-13:15
Lunch break (served in the meeting room)
13:15-13:45
(Lecture 3) Inspection practice – Planning and preparing an Inspection
Type of inspection, site-master-file modified for BE, Inspection team, Time Frame
Dr. Simonetta Pupella
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EuBIS
European Blood Inspection System
Initiated under the Public Health Programme of the EC – GA No. 2006202
5th International Seminar and Training Course – Istanbul, 14th - 17th of October 2014
Tuesday, the 14th of October 2014
13:45-16:00
Workshop I (Training Exercises)
13:45-16:00
Exercise 1 -
Design an inspection plan with several blood establishments
(different sizes and activity profiles )
Facilitator: Dr. Helga Marie Huber
Introduction:
Background and BE/CA information
Different audits plans are given to trainees
14:00 -14:45
Group Work:
- Group A
- Group B
- Group C
assisted by (CS, AA)
14:45-15:45
Plenary: Presentation of group work and discussion
15:45-16:00
Facilitator – Learning points and summary
16:00-16:20
Coffee break
16:20-16:40
(Lecture 4) Quality management of blood establishments
Standards and criteria of the EuBIS manuals and guide and its practical use
related to the Turkish blood transfusion system
Uzm. Dr. Nigar Ertugrul Oruc
17:00-18:00
Academy trainer debriefing day 1 / briefing day 2 (Lobby – Hotel)
Free evening
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EuBIS
European Blood Inspection System
Initiated under the Public Health Programme of the EC – GA No. 2006202
5th International Seminar and Training Course – Istanbul, 14th - 17th of October 2014
Wednesday, the 15th of October 2014
9:30-10:30
Seminar II - Quality management and inspections
EuBIS Manual and Training Guide – Practical Examples
9:30-9:50
(Lecture 5) Risk assessment and management of deviations in blood establishments
and reference to the EuBIS manual and guide
Dr. Alex Aquilina
9:50-10:10
(Lecture 6) Quality indicators for blood components for transfusion
and reference to the EuBIS manual and guide
Dr. Helga Marie Huber
Discussion (all participants)
10:30-10:50
Coffee break
10:50-17:00
Workshop II (Training Exercises)
10:50-12:00
Exercise 2 –
Blood collection and processing
Identification of non-compliances (Video exercises)
Facilitator: Dr. Simonetta Pupella
2.1 Blood collection (Video) 15 minutes
Facilitator: Dr. Alex Aquilina
Introduction: Scene and process
Individual work: Note of non-compliances (Individual)
Plenary: List of non compliances and discussion
2.2 Blood processing (Video) 15 minutes
Facilitator: Prof. Dr. Christian Seidl
Introduction: Scene and process
Individual work: Note of non-compliances (Individual)
Plenary: List of non compliances and discussion
Facilitator – Learning points and summary
12:00-13:00
Lunch break (served in the meeting room)
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EuBIS
European Blood Inspection System
Initiated under the Public Health Programme of the EC – GA No. 2006202
5th International Seminar and Training Course – Istanbul, 14th - 17th of October 2014
Wednesday, the 15th of October 2014
13:00-14:30
Exercise 3 –
Inspection report - Writing a comprehensive and
clear non-compliances report
Facilitator: Dr. Fewzi Teskrat
Introduction: Selected non-compliances from exercise 3 (video’s)
will be given to the trainees
Group Work:
- Group A
- Group B
- Group C
Plenary: Presentation of group results and discussion
Facilitator – Learning points and summary
15:30-16:30
Exercise 4.1 - Donor eligibility, blood donation, collection and processing
Facilitator: Dr. Helga Marie Huber
Introduction: 1st case study – Adverse event on blood processing
Group Work: - Group A
- Group B
- Group C
assisted by (CS and AA)
Plenary: Presentation of group results and discussion
Facilitator – Learning points and summary
16:30-17:00
Exercise 4.2
Quiz – Donor eligibility, collection and processing
Facilitator: Wiebke Siegel
17:00-17:30
Academy trainer debriefing day 2 / briefing day 3 (Lobby – Hotel)
19:30
Official EuBIS Joint Dinner Event
20:00 – 22:30
Meeting point: 19:30 tba
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EuBIS
European Blood Inspection System
Initiated under the Public Health Programme of the EC – GA No. 2006202
5th International Seminar and Training Course – Istanbul, 14th - 17th of October 2014
Thursday, the 16th of October 2014
9:30-10:00
Exercise 5 -
Quiz on quality assurance
Facilitator: Dr. Alex Aquilina
10:00-11:00
Seminar III - Quality management and inspections
9:30 – 9:50
(Lecture 7) General requirements for risk identification sand analysis
Dr. Fewzi Teskrat
9:50-10:10
Lecture (8) Inspection procedure after the inspection
Dr. Helga Marie Huber
Discussion (all participants)
11:00-11:20
Coffee break
11:20-13:00
Workshop III (Training Exercises and On-Site Visit)
11:20-13:00
Exercise 6
– Classification of non-compliances (Individual work)
Facilitator: Dr. Simonetta Pupella
Introduction: Classification of non-compliances using examples
Individual work: each participants is asked to classify and to use crossreferences to the EuBIS manual and guide
Plenary: Presentation of individual results and discussion
Facilitator – Learning points and summary
13:00 – 13:30 Lunch (short lunch) take your lunch for the Bus
Departure of Bus
14:00 – 16:30 On-Site Visit –Turkish Red Crescent Blood Transfusion Service
Return by Bus to Hotel
17:30-18:00
Academy trainer debriefing day 3 / briefing day 4 (Lobby – Hotel)
Free evening
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EuBIS
European Blood Inspection System
Initiated under the Public Health Programme of the EC – GA No. 2006202
5th International Seminar and Training Course – Istanbul, 14th - 17th of October 2014
Friday, the 17th of October 2014
10:00-12:30
Workshop III (Training Exercises and Role-Play)
10:00 - 12:30
Exercise 8 – Inspection completion Blood Transfusion Center
Report observations, prepare the closing meeting, prepare/evaluate an action plan
Facilitators: Dr. Fewzi Teskrat and Dr. Helga Marie Huber
Based on the Round Tour of the BE processes (Thursday)
● Blood Collection – Donor department
● Blood Testing – Laboratory Department
● Blood Processing
● Blood Storage and distribution
Introduction:
Part 1: Cases /Examples of observations (real life) will be presented. Participants are asked to
classify these, write a statement and use those reports to prepare the closing meeting
summarising the findings of the inspection report.
Group Work (3 groups):
- Group A
- Group B
- Group C
Part 2: Based on the cases/examples a response of the BE to the CA report is given to the
participants. Participants are asked to evaluate the action plan and prepare
corrections/modifications if required.
Plenary: Presentation of group results and discussion
Facilitator – Learning points and summary
12:30-13:30
Lunch break (served in the meeting room)
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EuBIS
European Blood Inspection System
Initiated under the Public Health Programme of the EC – GA No. 2006202
5th International Seminar and Training Course – Istanbul, 14th - 17th of October 2014
Friday, the 17th of October 2014
13:30-14:30
Exercise 9 –
Blood testing - role play (BE/CA)
Facilitators: Dr. Fewzi Teskrat and Dr. Helga Marie Huber
Introduction : Case and background information by Uzm.Dr. Nigar Ertugul Oruc
Group C: Observers, Reporter: Dr. Alex Aquilina
Briefing: Dr. Fewzi Teskrat
Group A (BE): group representing blood establishment
Group B (CA): group representing competent authority
Role play (group BE / group CA) Opening meeting – Findings – Closing meeting
Plenary: Comments by observers
Facilitator – Learning points and summary
14:30-14:45
EuBIS Training Course evaluation form
Dr. Simonetta Pupella
14:45-15:00
Concluding remarks and EuBIS Training Certificates
Uzm. Dr. Nigar Ertugrul Oruc
Prof. Dr. Christian Seidl
Dr. Fewzi Teskrat
15:00
End of EuBIS Training course
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EuBIS
European Blood Inspection System
Initiated under the Public Health Programme of the EC – GA No. 2006202
5th International Seminar and Training Course – Istanbul, 14th - 17th of October 2014
Seminar and training scope:
Comprehensive overview of commonly used standards and criteria summarised in the EUBIS manual and
training guide
Learn to define critical sub-processes for quality management
Advanced knowledge on how to use the cross-reference to commonly used standards and regulatory
requirements such as the
 EU blood directive
 GMP standards
 CoE (EDQM) guide
 PIC/S guidelines.
Learn common practice and get practical advice for the inspections of blood establishments
covering the
 collection,
 processing,
 testing,
 storage and distribution
of blood and blood components.
Practical exercises to train your knowledge in
 Planning of inspections and defining critical control points
 Risk based assessment and management of errors
 Observation and communication skills
 Classification of observations and errors
Finally the training course will be an excellent opportunity to meet experts in the field coming from
blood establishments and competent authorities.
Language skills:
English
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EuBIS
European Blood Inspection System
Initiated under the Public Health Programme of the EC – GA No. 2006202
5th International Seminar and Training Course – Istanbul, 14th - 17th of October 2014
Meeting venue*:
Istanbul is the largest city in Turkey, constituting the country's economic, cultural, and historical heart. With a
population of 14.1 million, the city forms one of the largest urban region in Europe and the second largest in the
Middle East by population within city limits. Istanbul has a transcontinental location, straddling the Bosphorus
—one of the world's busiest waterways—in northwestern Turkey, between the Sea of Marmara and the Black
Sea. Its commercial and historical center lies in Europe, while a third of its population lives in Asia.
The city of Istanbul has been known through the ages under a number of different names. The most notable
names are Byzantium and Constantinople. Byzantion, latinized as Byzantium, was founded by Greek colonists
in 667 BC. Much later, the name Byzantium became common in the West to refer to the Eastern Roman Empire,
the "Byzantine" Empire, whose capital the city had been.
Constantinople ("City of Constantine") was the name, in honor of Constantine the Great. Before the Roman
emperor made the city the new eastern capital of the Roman Empire on May 11, 330 AD, he undertook a major
construction project, essentially rebuilding the city on a monumental scale, partly modelled after Rome. For
nearly sixteen centuries following its reestablishment in 330 AD, it served as the capital of four empires: the
Eastern Roman Empire (330–395), the Byzantine Empire (395–1204 and 1261–1453), the Latin Empire (1204–
1261), and the Ottoman Empire (1453–1922). It was instrumental in the advancement of Christianity during
Roman and Byzantine times, before the Ottomans conquered the city in 1453 and transformed it into an Islamic
stronghold and the seat of the last caliphate. Although the Republic of Turkey established its capital in Ankara,
palaces and imperial mosques still line Istanbul's hills as visible reminders of the city's previous central role.
The modern Turkish name İstanbul is attested since the 10th century, in Armenian and Arabic sources. It derives
from the Greek phrase "εις την Πόλιν" [istimbolin] meaning "in the city" and is thus based on the common Greek
usage of referring to Constantinople simply as The City.

Reference: picture and text from wikipedia
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