Lounge Congress 2009

Lounge Congress 2009 - 7. - 19. March 2009, fair Karlsruhe more than 20 lectures of advisers from the industry and on the part of the authorities. Costs per day � 250, - during a registration by 31 December 2008. Parallel to the Lounges 2009 the first time of the Lounge Congress take place. The Congress is divided in three different parts and/or days, which present new projects, experiences from operator view and current Guidelines. Depending upon interest emphasis the Congress can be booked as entire or as single meeting. In the following an excerpt from the congress program: 17. March 2009PROCESSINGProzesse & Technology - production and handling HWSContainment against a Obligatorium for dedicated plants: RiskMaPP as an assistance during the conversion of I Q9 RiskMaPP (Risk based Manufacture OF Pharmaceuticals), an initiative of the ISPE (international Society for Pharmaceutical engineering) - scientific basis for the conversion of I Q9 of scientific toxicological justified limit values for cross contamination and cleaning validation alternative to mandatory dedicating of lying close the Containment as an important condition of a positive RiskMaPP AnalyseVor > the FDA suggested to 10 years requiring for certain critical products (e.g. cytotoxic cancer means) strictly separated production units like that as it for Betalaktame is mandatory. This proposal was not continued to pursue, but taken up now by the EMEA again. This announced a proposal for beginning of 2009 in the same direction. Also the WHO requires dedicated plants for the production of hormone products in a draft paper 2008. Would be effectless the risk analyses postulated by I Q9. During consistent conversion of such demands the production of many pharmaceuticals was senselessly raised the price of or verunm�glicht. RiskMaPP makes proposals, as transparent, scientifically well-founded individual case evaluations could be made. With positive result these would prove that production is permitted in general-purpose plants. Containment protects not only the cooperating in the enterprise separates forms also an important barrier from to high cross contamination. Concrete conversion examples are shown. Insulators for aseptisch, toxic production air circulation of zone concept contamination suitor filter change cleaning protection of individuals and product-protection-toxic products, which must be filled up aseptisch, make very high demands and the insulator. Topics such as air circulation, zone concepts, filter systems and cleaning must be summarized all in a project. On the basis a realized Projekes one points out, how " Gratwanderung" between GMP and from this the following product protection, as well as person security to be solved can. DevCon - CaseStudyvon Pfizer, Freiburg- Design criterion architectural and structural Design Containment/EHS compression phase video presentation the presentation Pfizer DevCon Facility contains the conception of the Design up to the realization of a OEB4-Entwicklungseinheit, which makes Containment technologies available to the development more again, highly effective materials. Part the presentation is a video demonstration, those the processes presents and some background informations gibt.18. March 2009FacilityProjekte & Planning - new ones and converted FacilitiesProjektmanagement in pharmaceutical IndustrieAls project sponsor, member of the steering committee or project manager answer for you substantial projects of your enterprise. Aims of the project and projects organization must be recognized be judged, crisis situations and met the correct decisions. Experiences show that in the starting phase the crucial development of project success is initiated. The following questions are to be answered: - On which does one have to respect at the start of the project purposefully? - Which are the crucial risk and success factors of projects? - Where is there advice and expert knowledge for difficult project situations? - As you develop an adequate project strategy? - Which decision collecting mains should expect you at least from your project team? - That you measure that your organization for the completion is optimally set up by projects? Successful enterprises convert innovations, investments and a majority of their core business over projects. Studies show that many are threatened by the failure such projects and can in most projects still at least 20% improvement potential be lifted. Factory planning: Development of complex production layouts in the far mA pharma-Industrie production requirement pure space zones/ex zone compression phases high-activity substance flow of material (logistics)/personnel river of fire compartments of escape routes it is described on the basis of examples the development of a space layout. Here on the basis by user and/or process requirements a room program is developed. This is supplemented and completed around technical aspects. On the basis the space and coded program a relations pattern set up that dependence and requirements functionally represents. From this in the next step a space layout is developed and optimized. To be considered various requirements and boundary conditions among other things must with such a layout planning (see above and technique ranges - to maintenance and maintenance/expandability/use flexibility). Some critical requirements and boundary conditions are described more in detail. One � PHARMAFABRIK" for the university hospital planning and building of a hospital pharmacy with GMP Herstellbereichen and extensive logistics functions as ready for occupancy solution for the university clinic Duesseldorf competition and Workshops of GMP laboratories for the production custom-made logistics binding to the automatic transport system high-quality job low-maintenance building engineering partnership completion model the result from the view operator with the goal in the future medicines, infusion and dialysis solutions, cytostatic drugs, to produce chemicals and Diagnostika also for third the university clinic offered a reward as one of the most important medical centers of the region the new building of a GMP fair pharmacy in the context of a VOF procedure. As a winner of this public competition the working group came out from C+P building team GmbH, society of the Carpus+Partner AG, Lindner clean-room technology and Imtech Duesseldorf. Was planned and realized a ready for occupancy, GMP fair pharmaceutical factory in the laboratory yardstick with extensive logistics functions. In close co-operation with the owner and a multiplicity of specialized divisions the project in given costing and date framework became realisiert.17. March 2009GMPNational & Internationally - new Regularien and EntwicklungGMP - Regulatori innovations and current development current changes of important GMP Regularien updates to selected European Union-Guidelines, national Regularien and publications to the conditions of science and technology. - In particular discussion of the contentwise changes of� - Annex 1 (version 2/2008, valid starting from 1.3.2009 bzw.1.3. 2010)� - Annex 2 (up-to-date valid version and revision draft) - current developments and points of discussion with the focus on SterilproduktionIn of the last time were published some important GMP Regularien in a revised version. As einpr�gsames example here the publication annex of the 1 is in the February 2008 mentioned, whose changed contents step mostly starting from 1 March 2009 into force. The well-known exception forms the part over flanges of Vials. It comes into force only to 1 March 2010, contain thus a comparatively comfortable, two-year transition period. Meanwhile nearly all companies concerned prepared at least concepts for the necessary changes and often also with the responsible authorities discussed. From the aspect of an GMP inspector an overview is to be given here. Also further GMP Guidelines, like e.g. the annex 2 over the production of biotechnological products, are subject at present to a revision. To a selection of different, Guides importantly judged by the author an overview of the contentwise changes is given. Finally also current developments and their points of discussion - with point of view sterile production - become angesprochen.ICH Q 10, CAPA & CO. - Which gives it new? - I quality vision CAPA - origin and definition Regularien - national and international CAPA vs. existing system expectations and experiences InspektorsICH of a Q 8, Q 9 and Q 10 - those are documents, which in the context in the year 2003 of the adopted quality vision to which I were provided. With the ICH-Q-10-Leitlinien is now also the last one of these documents in the stage 4 of the permission process and thereby for introduction in the three I regions (the USA, European Union, Japan) is recommended. The ICH-Q-10-Dokument describes a model for a pharmaceutical quality system that on concepts the ISO is based, GMP requirements includes and is closely with the sister documents I Q 8 and Q 9 intertwined. For the reaching of the quality goals one is the basis on the entire product life cycle oriented approach. Many terms, which admits from the range of ISO standards is, e.g. CAPA and KVP, find now predominantly GMP adjusted pharmaceutical quality world to entrance into those. In the lecture the requirements of a CAPA system, resulting from the ICH-Q-10-Dokument, as well as the entwinements with from the GMP range admitted to systems represented (e.g. Change or discrepancy control as well as OOS). In the end the Inspektorin opens � N�hk�stchen" for it; and chats over remarkable to this topic from its inspection practice. Handling highly effective substances (in drug and active substance production) from view of a GMP - inspector regulatorische requirements (insbsondere EEC-GMP-manual part of I, part of II, legal basic conditions, development of the right framework) - integration into a risk management system inspection considerations/space and AnlagenqualifizierungenDer handling highly effective substances represents not only challenges for the protection of individuals, but draws also a set of GMP - to problems with itself. The GMP Regularien in handling highly effective substances is represented for drugs and active substances and arranged in the Rechtssytematik as well as lit up from it resulting in consequences. The Regularien mentioned is embedded into a field changing legal basic conditions and is subject themselves even to the revision (e.g. chapter 3.6; 5,18 GMP manual). The interfaces of the different regulations as well as effects from the existing right surrounding field are pointed out. Finally for an inspection of the production of highly effective substances considerations which can be employed are discussed and different co-operation forms with the authorities before of projects are discussed. Detailed information to the Lounge Congress finds you here:

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