Microbiological Best Laboratory Practice - European Compliance ...

3-Day GMP Education CourseThis course will providepractice-oriented guidance onimplementing the harmonisedtest methods!MicrobiologicalBest Laboratory PracticeMastering the Challenges of Pharmacopoeias22 - 24 February 2010, Vienna, AustriaSPEAKERS:Colin BoothOxoidDr Sven M. DeutschmannRoche DiagnosticsDr Marcel GoverdeHoffmann-La RocheDr Holger KavermannRoche DiagnosticsArjan LangenLangen Pharmatraining andConsultingLEARNING GOALS:• Two Modules:– Validation according tothe Pharmacopoeias– The Real World• Develop testing and validationstrategies in four interactive Sessions:– Harmonized methods for testingof non-sterile products- Specified organisms- Endotoxin testing- Environmental monitoring• Latest Trends in MicrobiologicalQuality Control

Microbiological Best Laboratory Practice22-24 February 2010, Vienna, AustriaObjectivesMost tests applied in microbiological QC are describedin detail in the different Pharmacopoeias (e.g. EP, USP,JP). These methods are regarded as being validated –but not for your products!In the end, it is up to you to prove that the officialmethods function in your environment. The validation ofmicrobiological test methods for your needs consumes alot of time, money and manpower. Things can get morecomplicated if your products interfere with the executionof the test.The real challenge is to fulfil both, regulatory requirementsand at the same time financial targets set byyour management.During this 3-day workshop you develop strategies for asustainable approach to the validation of microbiologicaltest procedures. This course will give you clear guidanceon how to cope with these tasks besides your routinelaboratory work.The key tool of this seminar will be team work. During interactivesessions you will create procedures for the mostcommon microbial test methods. Our experienced ECAcourse leaders will moderate the discussions to lead youto practice-oriented solutions.After completion of the course you will be able to copewith the validation of microbiological test procedures ina compliant and at the same time efficient manner.To guarantee optimal conditions for the exchange ofopinions and experiences, the number of participantsis limited!This course will provide practical guidance on implementingthe harmonized test methods!Target GroupThis GMP workshop is designed for• microbiologists,• managers and supervisors of pharmaceuticalmicrobiological laboratories.Furthermore, the course will be of interest to personnelfrom•••quality control,quality assurance,regulatory affairs andcontract laboratories,•involved in the microbiological aspects of theproduction and testing of medicinal products.Module 1: 22 February 2010Validation According to the PharmacopoeiasValidation Requirements• Designing a validation strategy• Worked examples of validation, creams, liquids, tablets• Sterility test validation, why do so many laboratoriesget it wrong?• Validation of difficult formulations• Validation and robustness - are they the same thing?• Transferring methods to other laboratories, whatvalidation do you need?Colin Booth, OxoidMaterials Needed for the Validation• Microbial cultures, selection and maintenance• Microbiological media: how to make it, store it and test it• Routine validation of your QC laboratory instruments.• Managing your stock, laboratory inventory.Colin Booth, OxoidThe Test of Sterility: Critical Parameters for a Validationof the Test Procedures• Media• Validation tests• Test procedures- Membrane filtration method- Direct transfer or direct inoculation methodSven M Deutschmann, RocheBacterial Endotoxins/Test Validation• Principles of the techniques- Gel-clot techniques- Photometric techniques• Preparatory testing / validation testsColin Booth, OxoidTests for Specified Microorganisms• Implementation of the harmonised methods• Challenges concerning the suitability testing• How to choose the right growth media supplier• What are objectionable micro-organismsMarcel Goverde, RocheEfficacy of Antimicrobial Preservation• Test organisms• Preparation of inoculum• Procedure• Criteria of acceptance• Comparison Ph.Eur. – USPColin Booth, OxoidMicrobial Limit Test for Non-sterile Products• The harmonised approach USP/Ph.Eur. /JP• Relevant parameters in the test procedure• Choosing the most suitable test method• Suitability test: what should we report?• Microbial quality of excipients, API and final dosage forms• The approach of risk assessment testingMarcel Goverde, Roche

Module 2: 23 - 24 February 2010The Real WorldInteractive SessionsYou will participate in 3 workshops!These interactive sessions are an excellent forum forfruitful discussions. You will develop testing and validationstrategies that can be transferred directly to yourlab. The ECA course leaders take care that you stayfocused on the pre-defined exercises.The Harmonized Methods for Testing of Non-sterileProductsThe goal of this workshop is encourage the participantsto think globally when analyzing microbiology problems.Microbiology problems are subtle and often multifactorialin their origin. The workshop will show youtips and tricks in testing methods and a possibility todiscuss the issues of the implementation of the harmonizedmethods like growth promotion testing, creatingan implementation concept and necessary investments.Marcel Goverde, RocheRapid Microbiological MethodsThis workshop offers you a unique possibility to evaluatethe new developments in RMM systems to extendthe experiences in validation and implementation ofthese systems in pharmaceutical industry. Furthermoreyou will learn more about the expectations of Europeanand US authorities.Sven M. Deutschmann, Holger Kavermann, RocheEndotoxin TestingRoutine endotoxin testing should be straightforward,sometime there are problems in the assay, we will exploreexamples of faults that have occurred in routinetesting, and how to fix them. However the major part ofthis workshop will be to work through problems of validatingthe assay both in Gel Clot and in the KineticChromogenic assays. We will review data from real examplesand discuss the options for resolution of the issues.Colin Booth, OxoidEnvironmental MonitoringThe workshop gives you an understanding of how toset-up an environmental monitoring programme, andhow to handle excursions. The discussions will focus oninitial qualification vs. routine monitoring, how manysamples are reasonable, reporting structure of environmentalmonitoring data, corrective actions and the impactof environmental data on product release.Arjan Langen, Arjan Langen Pharma TrainingRapid Microbiological Methods• Overview on the current RMMs• Limitations and benefits of the different RMM?Sven M. Deutschmann, Marcel Goverde, RocheDealing with OOS-Results• How do we define alert and action limits?• How should we react on Out-Of-Specification results?• How can we perform a proper Failure Investigation?Sven M. Deutschmann, RocheChange Control and Training of New Personnel• Capturing changes in your process• When is a change not a change?• Change control after the event• Your change control process, making it robust• A structured training programme for microbiologists,what they need to know and whyColin Booth, OxoidIdentification Techniques – Phenotypic / Genotypic• Phenotypic and genotypic identification techniquesadvantagesand limitations• A change from phenotypic to genotypic identificationand the surprises• New Methods - what’s in sight?Holger Kavermann, RocheSpeakersColin BoothOxoid, UKColin was the manager of pharmaceutical microbiologyof Glaxo Wellcome Research and Development based inthe UK where he was responsible for all the microbiologyassociated with the development of all Glaxo Wellcomenew products. In 2002 he joined Oxoid Limitedwhere he is now Vice President Science and Technology.He is an ECA Advisory Board Member covering the fieldof Development Microbiology.Dr Sven M. Deutschmann,Roche Diagnostics GmbH, GermanySven Deutschmann studied biology at the University ofBraunschweig where he obtained his PhD in cell culturetechnology. In 1995 he joined Boehringer MannheimGmbH, now Roche Diagnostics GmbH, as Manager QC.He was responsible for the microbiological and cell biologicalanalytics of QC and In-Process-Control samples inthe production of biotechnological derived active pharmaceuticalingredients and for the environmental monitoringprogram in the production areas. Since 2001 he isDirector of the Microbiology QC Department. Dr Deutschmannis member of the Microbiology Commission ofthe German Pharmacopoeia Commissions and specialist

esp. member in several Working Parties of the PharmacopoeiaCommissions. Recently, Dr Deutschmann wasappointed Chairman of ECA‘s Working Group for RapidMicrobiological Methods (RMM).Dr Marcel GoverdeHoffmann-La Roche AG, SwitzerlandMarcel Goverde has attended the University of Basel,where he majored in biology. After one year of workingfor the agro biological department of Novartis, he led adevelopment project on sustainability and education inCosta Rica. After returning to Switzerland he earned hisPhD in ecology at the University of Basel where he subsequentlywas employed as an academic tutor. Since2002 he is leading the quality control lab for non-sterileproducts as well as the lab for research & developmentof microbiological methods at F. Hoffmann-La Roche Ltdin Basel. Furthermore he is a member of the working partyfor Modern Microbiological Methods (MMM) from theEuropean Directorate for the Quality of Medicines(EDQM).Dr Holger KavermannRoche Diagnostics GmbH, GermanyHolger Kavermann studied microbiology at the Universityof Göttingen and obtained his PhD in medical microbiologyat the University of Munich. In 2003 he joinedRoche Diagnostics GmbH, as Manager QC. He is responsiblefor the microbiological and cell biological analyticsof QC- and In-Process-Control-samples in the productionof biotechnological derived active pharmaceuticalingredients.Arjan Langen,Langen Pharmatraining and ConsultingArjan Langen was manager of Microbiological QualityControl and Quality Assurance officer at Intervet Internationalin The Netherlands before he joined Nobilon International.At Nobilon he was appointed Quality AssuranceManager, responsible for the cGMP-approval of the newmulti-purpose vaccine production facility in Boxmeer ,The Netherlands. 2008 Arjan takes over the position ofDirector Compliance at DSM. 2009 he founded his owncompany for training and consulting. He is a member ofthe PDA and a member of the Dutch Society of PharmaceuticalMicrobiology.Social EventAt the end of the second day of the event you are invitedto take part in an informal dinner where you can discusswith speakers and colleagues in a relaxed atmosphere.

Easy RegistrationReservation Form: CONCEPT HEIDELBERGP.O. Box 10 17 6469007 HeidelbergGermanyReservation Form:+ 49 6221 84 44 34@ e-mail:info@concept-heidelberg.de Internet:www.gmp-compliance.orgConference languageThe official conference language will be English.DateModule 1:Monday, 22 February 2010, 09:00 – 17:30 h(Registration and coffee 8:30 – 9:00 h)Module 2:Tuesday, 23 Febraury 2010, 09:00 – 17:30 h(Registration and coffee 8:30 – 9:00 h)Wednesday, 24 February 2010, 08.30 – 13:00 hVenueSteigenberger Hotel HerrenhofHerrengasse 101010 Vienna, AustriaPhone +43 (0)1 53404 0Fax +43 (0)1 53404 844FeesModule 1:Non-ECA Members EUR 890.- per delegate plus VATECA Members EUR 801.- per delegate plus VATEU GMP Inspectorates EUR 445.- per delegate plus VATAPIC Members EUR 845.- per delegate plus VAT (does notinclude ECA Membership)Module 2:Non-ECA Members EUR 1,490.- per delegate plus VATECA Members EUR 1,341.- per delegate plus VATEU GMP Inspectorates EUR 745.- per delegate plus VATAPIC Members EUR 1,415.- per delegate plus VAT (does notinclude ECA Membership)Save up to EUR 400 by registering for both Modules!Module 1 and Module 2:Non-ECA Members EUR 1,980.- per delegate plus VATECA Members EUR 1,791.- per delegate plus VATEU GMP Inspectorates EUR 995.- per delegate plus VATAPIC Members EUR 1,881.- per delegate plus VAT (does notinclude ECA Membership)The conference fee is payable in advance after receipt ofinvoice and includes conference documentation, dinner onthe 23rd, lunch on 22nd and 23rd and all refreshments. VAT isreclaimable.AccommodationCONCEPT has reserved a limited number of rooms in theconference hotel. You will receive a room reservation formwhen you have registered for the event. Please use this form foryour room reservation or be sure to mention “VA 6290 ECAEvent” to receive the specially negotiated rate for the durationof your stay. Reservation should be made directly with thehotel not later than 22 January 2010. Early reservation isrecommended.RegistrationVia the attached reservation form, by e-mail or by fax message.Or you register online at www.gmp-compliance.org.Organisation and ContactCONCEPT HEIDELBERGP.O. Box 10 17 64D-69007 HeidelbergGermanyPhone +49 (0) 62 21/84 44-0Fax +49 (0) 62 21/84 44 34E-mail: info@concept-heidelberg.dewww.concept-heidelberg.deFor questions regarding content:Axel H Schroeder (Operations Director)at +49-62 21 / 84 44 10, or per e-mail atschroeder@concept-heidelberg.de.For questions regarding reservation, hotel, organisation etc.:Ms Jessica Stürmer (Organisation Manager)at +49-62 21 / 84 44 43, or per e-mail atstuermer@concept-heidelberg.de.About CONCEPT HEIDELBERGFounded in 1978, CONCEPT HEIDELBERG is the leadingorganiser of seminars on pharmaceutical production, qualitycontrol, quality assurance and GMP in Europe. This year morethan 240 events will be organised by CONCEPT HEIDELBERG.ECA has entrusted CONCEPT HEIDELBERG with the organisationof its events.What Is ECA?The European Compliance Academy (ECA) is an independenteducational organisation chaired by a Scientific Advisory Boardwith members of the pharmaceutical industry and regulatoryauthorities.The ECA will provide support to the Pharmaceutical Industryand Regulators to promote the move towards a harmonised setof GMP and regulatory guidelines by providing informationand interpretation of new or updated guidances.What Are the Benefits of ECA?First benefit:During the membership, you enjoy a 10 %discount on the regular participation fee ofany European Conference organised by ECAin co-operation with CONCEPT HEIDEL-BERG.Second benefit:The Guidelines Manager Software with a large number ofguidelines, e.g. EC Directives, FDA Guidelines, ICH Guidelines,will be forwarded to you when you are using your membershipfor a conference registration.How Do You Become a Member of ECA?By participating in one of the European Compliance Conferencesor Courses marked with ECA, you will automaticallybecome a member of ECA for two years – free of charge.Conferences and Education Courses organised by ECA will berealised in co-operation withwa/vers1/300709