SPEAKERS:

Barbara GertenMerck Millipore

Prof Dr Diana GraubaumBeuth University of Applied Sciences

Alexander BartesRoche Diagnostics

Erika TranfieldBruker UK Ltd

Martina HeldBeuth University of Applied Sciences

Beate VolkBeuth University of Applied Sciences

LEARNING GOALS:

� Introduction into the microscopy and identification of micro organisms

� Processing and evaluation of prepared cultures from different areas, e.g. - environmental monitoring, - water

� Preparation of pure cultures

� Identification with molecular genetic rapid methods

� Identification with MALDI-TOF MS

� Identification with manual biochemi-cal methods

� Basic knowledge yeast and moulds identification

Microbiological Identification

9-11 March 2016, Berlin, Germany

From biochemical to genotypic to mass spectrometric methods

This education course is recognised for the ECA GMP Certification Programme „Certified Microbiological Laboratory Manager“. Please find details at www.gmp-certification.eu

� Small groups � Microscope for every participant � 1 instructor per 3 participants � Extended part yeast and mould ID � Comprehensive image documentation

Hands-on Laboratory Training Course

Objectives

You will learn how to recognise microbiological cultures. You will further get to know classical pro-cedures for the selection and identification and how to analyse the microbiological concept. In addition you will get an insight into the needed media and in modern rapid methods.

Due to the limited number of participants and the supervision by experienced lab staff you will be able to do the work, to employ the methods and to make the analyses yourself. For that pur-pose there will be lab places with microscopes in the S2 lab for every participant. Accompanying presentations and a comprehensive documenta-tion will provide the necessary knowledge base.

Background

Microbiological trainings are commonly based on presentations or theoretical workshops. Quite fre-quently there is either no advanced practical train-ing at all or it is only very limited.

This completely new designed lab course is sup-posed to be an extension of the microbiological seminars as part of the GMP Certification Pro-gramme “Microbiological Laboratory Manager”.

Target Audience

Personnel from labs for � Quality Control � Hygiene � Monitoring

with basic microbiological knowledge.

A special thanks for supporting this course goes to VWR BioMérieux, Roche Diagnostics, Bruker, Dr. Weigert GmbH and Merck Millipore.

Programme Wednesday, 9 March 2016, 10.00-18.00 h

� Welcome and organisational issues � Basic knowledge Identification of microorganisms

� Introduction into the work with microscope and identification of microorganisms

� Handling and examination of prepared cul-tures (different samples e.g. environmental monitoring, water on contact plates, swabs, membranes)

� Preparation of pure cultures � Introduction in microscopy � Gram and spore staining � Biochemical rapid tests

Thursday, 10 March 2016, 09.00-17.30 h

� Overview Molecular genetic methods and Mycoplasma detection

� Identification with Maldi-TOF MS � Practice in manual biochemical identification methods (Multi-Test-Systems, additional tests)

� Practice in molecular genetic rapid methods using the example of Mycoplasma detection

� Practice in identification of bacteria, yeast and moulds by MALDI-TOF MS

Friday, 11 March 2016, 08.30-15.30 h

� Analysis of the results from molecular genetic rapid methods, MALDI-TOF MS and manual biochemical methods

� Consolidation and discussion of all results � Basic knowledge and practice of yeast and moulds identification including microscopy

� Report/findings � Beneficial literature

Microbiological Identification – Hands-on Laboratory Training Course

9-11 March 2016, Berlin, Germany

Speakers

Prof Dr Diana GraubaumBeuth University of Applied Sciences, BerlinDiana Graubaum studied veterinary medicine at the Free University Ber-lin. She get her degree in 2003 and worked since 2001 as scientist at the

FU Berlin. Currently she is the Head of Section V Food Microbiology at the University for Applied Sciences.

Barbara Gerten Merck Millpore, Darmstadt, GermanyAfter her studies in microbiology and biochemistry, Barbara Gerten was employed in different compa-nies responsible for Quality Control and Research and Development.

Since 2008 she is head of the laboratory RTU Me-dia / Validation at Merck KGaA, today Merck Mill-pore. She is a member in several national and in-ternational bodies of microbiological topics in ISO and CENand a member of RCAs RMM advi-sory board.

Alexander Bartes Roche Diagnostics, Penzberg, GermanyAlexander Bartes studied chemical engineering with emphasis on biotechnology and genetic en-gineering at the University of Applied Science Aachen/Jülich, Germany. After completion of his master thesis at Roche Bioscience, Palo Alto, CA, USA he joined Roche Diagnostics, Penzberg in 2002. 2009 – 2014 he was Manager R&D. He was responsible for the development of qPCR/NAT based assays and Kits for Roche Applied Science Custom Biotech. Currently he worked at Roche in the Microbiology QC department.

Erika TranfieldBruker Ltd, United KingdomErika worked from 2009-2011 as Ap-plication Specialits at Bruker Dal-tronics. Since 2010 she is Applica-tion Specialist MALDI Biotyper and Demonstrations lab Manager at

Bruker UK Limited.

Social Event

On the evening of the first course day you are cor-dially invited to a social event. This is an excellent opportunity to share your experiences with col-leagues from other companies in a relaxed atmos-phere.

GMP Certification Programme

This seminar is recognised within the GMP Certification Programme ”Microbiological Laboratory Manager”. By attending selected seminars, the participant can ac-quire an additional certificate. We offer the following modules:

ECA Certified Validation Manager ECA Certified QA Manager ECA Certified API Production Manager ECA Certified Quality Control Manager ECA Certified Technical Operations Manager ECA Certified Computer Validation Manager ECA Certified Regulatory Affairs Manager ECA Certified Microbiological Laboratory Manager ECA Certified Sterile Production Manager ECA Certified Biotech Manager ECA Certified Pharmaceutical Development ManagerECA Certified GMP AuditorECA Certified GDP Compliance Manager

On the internet at www.gmp-compliance.org you will find a text explaining which seminars are recognised for which certificates. Or you send an e-mail to info@gmp-compliance.org or a fax to +49-6221- 84 44 64 with the request for infor-mation about the GMP Certification Programme. We will then send you our brochure on the topic.

Rese

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Date

Wednesday, 09 March 2016, 10.00 – 18.00 (Registration and coffee 09.30 -10.00 h)Thursday, 10 March 2016 , 08.30 -18.00 h Friday, 11 March, 08.30 – 15.30 h

Venue of the hands-on Laboratory Training Course:

Beuth Hochschule für Technik, Labor für Lebensmittel Mikro-biologie (Beuth University of Applied Science, Laboratory for Food Microbiology)Forum Seestraße, Seestraße 64, 13347 Berlin, Room FS 338

Special remark: By the law of the hosting country, working in a S2 Laboratory during pregnancy is not allowed. Therefore, pregnant participants will be excluded from attendance.

Hotel (Overnight stay only)

InterCityHotel Berlin HauptbahnhofKatharina-Paulus-Straße 5 10557 Berlin, GermanyPhone +49 (0) 30 288 755 0Fax +49 (0) 30 288 755 900

Fees (per delegate plus VAT)

ECA Members € 2,190 APIC Members € 2,290Non-ECA Members € 2,390EU GMP Inspectorates € 1,195The conference fee is payable in advance after receipt of in-voice and includes conference documentation, lab materi-als, bus transfer from hotel to laboratory, dinner on the first day, lunch on all three days and all refreshments. VAT is re-claimable.

Accommodation

CONCEPT has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form with all further information when you have registered for the course. Early reservation is recommended.

Registration

Via the attached reservation form, by e-mail or by fax mes-sage. Or you register online at www.gmp-compliance.org.

Organisation and Contact

ECA has entrusted CONCEPT HEIDELBERG with the organisation of this event.

CONCEPT HEIDELBERGP.O. Box 10 17 64, 69007 Heidelberg, GermanyPhone +49 (0) 62 21/84 44-0, Fax +49 (0) 62 21/84 44 34info@concept-heidelberg.de | www.concept-heidelberg.de

For questions regarding content: Mr Axel Schroeder (Operations Director) at +49-(0)6221/84 44 10, or per e-mail at schroeder@concept-heidelberg.de.

For questions regarding reservation, hotel, organisation etc.: Mr Rouwen Schopka (Organisation Manager) at +49-(0)6221/84 44 13, or per e-mail at schopka@concept-heidelberg.de.

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Reservation Form:CONCEPT HEIDELBERGP.O. Box 10 17 6469007 HeidelbergGermany

Reservation Form:+ 49 6221 84 44 34 @ e-mail:

info@concept-heidelberg.de Internet:www.gmp-compliance.org

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Daily bus transfers from the hotel to the Laboratory and back are included.