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All publications for the rubric Standards, Guidelines

Pharmadidact-Praktikum: Probenahme und Analytik bei der Reinigungsvalidierung am 31.05.2011 in Göttingen

18.03.2011
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Knowledge & Events

Pharmadidact practical course: Sampling and analytics during the cleaning validation to 31.05.2011 in Goettingen

An interview with Friedrich Gï¿½nnewig, gang village pharmaceutical GmbH gentleman Gï¿½nnewig, Sie a PTS practical course to sampling and analytics during the cleaning validation planned. What is for a practical course? In the PTS practical course we dedicate ourselves particularly to the samp…

Neuerungen und Trends im regulatorischen Bereich 2010/2011

29.01.2011
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Knowledge & Events

Innovations and trends within the regulatorischen range 2010/2011

In the European Union: Actualization of the European Union-GMP-manual, part of 1, chapter 5 and 7 the revision of chapter 5 part of the 1 of the GMP manual serves the stress of the importantness of the delivery chain of raw materials. Sections concern the end of 2010 published changes to chapter 5 f…

Risikomanagementsysteme, Sterilfertigung, Kosten senken durch Compliance

05.01.2011
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Knowledge & Events

Risk management systems, sterile manufacturing, costs lower by Compliance

Pieces of news of the 16. GMP KonferenzDie I guidelines Q 8 ï¿½ quality by Design" , Q 9 ï¿½ quality Risk Management" and Q 10 ï¿½ quality Systems" entrance into the Regularien found. Thus systematics of the quality risk management (QRM) are described in detail in annex 20 of the European U…

Erstes Zertifikat Good Quality Practice GQP für Heidi Friesacher

22.12.2010
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Knowledge & Events

First certificate Good quality Practice GQP for Heidi Friesacher

Qualification is the key in the competition around interesting and lucrative jobs. Heidi Friesacher has this key now in the hand. Professor Dr. Ingrid Mueller, who doziert as Studiendekanin of the course of studies Pharmatechnik at the university Albstadt Sigmaringen, presented the certificate on 22…

Reinigung und Reinigungsvalidierung - immer noch aktuell?

08.11.2010
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Knowledge & Events

Cleaning and cleaning validation - still current?

In the discussion: Dr.Axel ship man, F. Hoffmann La Roche AG and Cornelia WawretschekReinigung and cleaning validation to 5. - 6.Oktober in Binzen - proximity Basel Dr. Schiffmann, for three years are you in the team of the specialized moderators of the seminar cleaning and cleaning validation. What…

GMP-Mitarbeitertraining ? smart und gut!

20.07.2010
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Knowledge & Events

GMP Mitarbeitertraining ï¿½ smart and well!

In the discussion: Dr. Maria break and Cornelia WawretschekFrau Dr. break, PTS training service its training offer by PTSsmart extended. What is PTSsmart? Can PTSsmart replace the internal coworker training? Yes, PTSsmart is a new training concept, which can support or replace the coworker training…

16. GMP-Konferenz: Risikomanagement, Sterilfertigung, Compliance am 22.-23.11.2010 in München

07.06.2010
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Knowledge & Events

16. GMP conference: Risk management, sterile manufacturing, Compliance to 22. - 23.11.2010 in Munich

In the focus of the quality systems are located at present in particularï¿½ Risk management, sterile manufacturing as well as Compliance. These aspects are from there the conference topics in 2010. The presentations from authorities and industry light up the practical conversion, supplemental ove…

Validierung - Status, Trends und Ausblick

06.05.2010
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Knowledge & Events

Validation - status, trend and view

Author: Michael trained of: 28.04.2010Die still current FDA Guideline on general Principles OF Process Validation is now over 20 years old. The document from May 1987 stands for Industry from November 2008 before substantial contentwise changes and/or Neuentwicklungen.Die effects on the topic of the…

Das Thema Schulungen hat sein stiefmütterliches Dasein verloren!

23.04.2010
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Knowledge & Events

The topic training courses lost its stiefmï¿½tterliches existence!

Author: Dr. Maria break, PTS training service to examine www.pts.eu at the latest with the demand for manufacturers or pharmaceutical entrepreneurs the success of the instructions (AMWHV) the topic training courses a central element of the quality assurance became. Also for the medicine product manu…

Eine Krise - Das Ende aller Maßnahmen zur Weiterbildung?

11.03.2010
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Knowledge & Events

A crisis - the end of all measures for further training?

Author: Michael training places it itself nevertheless once a well received old tare balance forwards. On the one side sit those, which say: ï¿½ now where no more money seems to be, must we there first the costs of training courses and further educations to the market situation anpassen." From it…

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