Aktuelle Änderungen auf regulatorischen Gebieten im zweiten Halbjahr 2012

In Deutschland

Zweites Gesetz zur Änderung arzneimittelrechtlicher Vorschriften

Im Oktober des vergangenen Jahres ist das zweite Gesetz zur Änderung arzneimittelrechtlicher und anderer Vorschriften veröffentlicht worden. In diese…

Der Gesetzgeber hat Erwartungen an das Unternehmen hinsichtlich Reinigung. Inhalte dazu finden sich beispielsweise in der AMWHV in § 5, Betriebsräume und Ausrüstungen, in § 6, Hygienemaßnahmen oder in§ 12, Personal in leitender und in verantwortlicher Stellung.

So ist festzulegen, wann und in welchem Umfan…

„Gibt es ein praktisches PTS-Seminar zum Thema Probenahme bei der Reinigungsvalidierung? Ein Seminar, bei dem ich eine praktische Anleitung erhalte, wie ich richtig beproben muss, und lerne, welche Analysenmethoden zur Anwendung kommen?“ Mit diesen Fragen hatte die junge Frau ins Schwarze getrof…

A characteristic of PTS offers is the practice proximity and the conversion of our topics of the seminar � live � locally. Leave yourselves of� experienced of many years adviser into the operational operational sequence kidnaps and enjoys you apart from the theory also practice with P…

In draft of change of Germany to the drug law (AMG) the Federal Ministry submitted a bill, with which the AMG in addition, various other drug-relevant regulations are to be changed. Substantial innovations are not contained, since it concerns adjustments predominantly to well-known demands out of EU…

New from the European union (European Union) draft of one I Q 11Als addition of I the Q 8 published the EMA a draft of one I Q 11 for commentating, which with the development of chemical-synthetic and biotechnical active substances concerns itself. Because of the very abstract and general representa…

Already since 1993 the quality stands in the center of the enterprise example of PTS training service. The audit in September 2011 confirms the high level for planning and execution of Weiterbildungsveranstaltungen.Das new certificate is valid now for further three years. The customers can trust thu…

Secret winners are better admit under the English term Hidden champion. These are relatively unknown small enterprises, which take a prominent role in their market however. PTS training service is such a specialist for further training in far mA, active substance and medicine product sector. The uni…

� there is a practical PTS seminar to the topic sampling during the cleaning validation? A seminar, with which I receive a practical guidance, how I must beproben correctly, and learn, which analysis methods to be used? " With these questions the young woman had met: Not would a seminar be mean…

Innovative active substances and drugs become ever more active. Active substances in the early phase of the development are pharmakologisch and examined for their impact on the environment often not completely. From there these materials are to be always estimated in accordance with the precaution p…