5 International EuBIS Seminar and Training Quality management and inspection criteria
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 nd 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 2 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. 3 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) 4 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 5 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 6 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) 7 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 8 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 9 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) 10 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 11 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 12 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 13
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