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All publications for the rubric Standards, Guidelines

Kreuzworträtsel als ein Mittel zur Erfolgskontrolle

02.03.2010
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Knowledge & Events

Cross word mystery as a means to the progress control

The PTS Fachmoderatorenteam already set the GMP trend progress control with the meetings starting from summer 2007 into the practice. Gladly we place our examples of a progress control of your employment to the planning and execution of trainings in the own enterprise to the order. As a variant thos…

01.02.2010
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Standards, Guidelines

Conditions for good air

The guideline describes quality requirements to central spatial air-technical lying close and is focused on the structural and the technical requirements. In the revised version of the guideline the changed international standards are considered and more extensively described the aspects of the ener…

Aktuelle regulatorische Änderungen in der EU und Neuigkeiten im Bereich steriler Arzneiformen

19.01.2010
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Knowledge & Events

Current regulatorische changes in the European Union and pieces of news within the range of sterile medicine forms

In the EUï¿½nderungen with the ArzneimittelzulassungenAm 1 January 2010 the new regulation 1234/2008 stepped current regulatorische changes from 24 November 2008 over the examination of changes of the permissions of human and animal drugs into force. It serves the harmonization of the valid natio…

15. GMP-Konferenz in München: Treffpunkt für Industrie, Behörde und Hochschule

19.01.2010
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Knowledge & Events

15. GMP conference in Munich: Meeting place for industry, authority and university

The series of lectures to 23. - 24.November 2009 in Munich stretched a far sheet of the pharmaceutical package tied in the European union over the installation from risk management systems to the supplier management. If the meeting was supplemented by panels and Round Tables.Andreas Ellmaier conveye…

25.11.2009
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Standards, Guidelines

Recognized rules of the technology (aRdT)

Important terms, which emerge during all engineer achievements, are such like state of the art or middle kind and Gï¿½te.Es are this so-called indefinite right terms. This to make concrete to make objektivierbar and understandable is a goal of the technical rule setting. In addition the appreciat…

Neue Herausforderungen in der Reinraum- und Nanotechnik

23.09.2009
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Standards, Guidelines

New challenges in the pure space and nano-technology

The 13. VDI trade conference clean-room technology to 26. and 27 October 2009 in Frankfurt A.M. takes up for the first time as a main topic the clean-room technology and contamination control from the point of view of the nanotechnology. Under pure space conditions all run the processes, which to th…

01.03.2009
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Consulting

GMP training courses for all ï¿½ also for outside firms

Enterprises, those within a GMP requiring range work guarantee the adherence to the GMP rules by your coworkers. But these enterprises can be also safe that the coworkers of outside firms have this GMP knowledge? With GMP: READY can be trained the coworkers by outside firms before their first employ…

VDI 2083 Blatt 3 Beiblatt - Reinraumtechnik; Messtechnik; Monitoring

01.03.2009
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Standards, Guidelines

VDI 2083 sheet 3 supplement - clean-room technology; Measuring technique; Monitoring

The sequential monitoring of pure areas is not so far standardised. Everyone makes from there, what correct it considers. Within some ranges, usually legally he does regulated, within which the operator is dependent on the judgement of an official inspector, then intelligent-proves what correct the…

VDI 2083 Blatt 9.2 - Reinraumtechnik; Verbrauchsmaterialien

01.03.2009
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Standards, Guidelines

VDI 2083 sheet 9,2 - clean-room technology; Expendables material

Whether the glove shown in the picture is clean spacesuited in principle, I cannot at all say to you, because products as he are used into large quantities in the controlled range, are however neither in their characteristics still regarding of representativer customs cycles and/or - test parameter…

20.01.2009
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Knowledge & Events

PTS - Brochures: Donations instead of buy

These brochures are a Kundenservice of PTS training service and in the context of selected trainings to the participants are handed out. They cannot acquire this brochure available. If you want to use the brochures in the context of your training conception, a donation can be transferred in favor of…

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