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CCS News Ticker:

  • LOGFILE Nr. 02/2018 – Regulatorische Anforderungen an ein elektronisches Chargendokumentations- und Freigabesystem Welche regulatorischen Anforderungen sind bei der Umsetzung eines elektronischen Chargendokumentations- und Freigabesystems (EBR) zu beachten? Lesen Sie hier mehr online (externer Link)
  • Das Seminar wendet sich an alle Sachkundige Personen/ QPs. Ebenfalls angesprochen sind Leiter und Mitarbeiter von Qualitätsmanagement und Qualitätssicherung und Mitglieder der Unternehmensleitung, die einen umfassenden Überblick über Pflichten und Aufgaben der sachkundigen Personen/QPs erhalten mochten: Qualified Person Update 2018 – Neues für die Sachkundige Person in Deutschland;   19./20. April 2018, Mannheim Zum Online – …
  • The goal of this GXP guidelines document is to provide life sciences organizations with a comprehensive toolset for using Microsoft Azure while adhering to industry best practices and applicable regulations. It identifies the shared responsibilities between Microsoft and its life sciences customers for meeting regulatory requirements, such as US-FDA 21 CFR Part 11 Electronic Records, …
  • 8 February 2018, Stuttgart, Germany (9 am to 5 pm) Venue: Milaneo Office Center, Heilbronner Straße 74, Stuttgart, Germany The programme will focus on regulated companies that are in the process of the implementation and validation of software development tools like JIRA, BitBucket and Confluence (Atlassian). If such tools are used for GXP activities (GMP, GLP, GDP, GVP, GCP) or medical …
  • 1 November 2017 marks the coming into operation of further aspects of the mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories. This agreement, which updates the agreement from 1998, allows for recognition of each other’s inspection …
  • Read our new article on LinkedIn: Software Development Validation of SDLC tools like Confluence, JIRA according ISPE GAMP 5.
  • The Conference is designed for all Qualified Persons and aspiring Qualified Persons. It also addresses upper management functions and authority representatives who want to be informed about the latest development regarding the duties and responsibilities of Qualified Persons. 29. and 30. September 2017 Venue Best Western Hotel M 56a Bulevar Oslobođenja Street, Belgrade Read more: …
  • The US FDA Agency  was announcing the availability of a draft guidance for industry entitled ‘‘Use of Electronic Records and Electronic Signatures in Clinical Investigations under our regulations—Questions and Answers.’’ The draft guidance provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic records …
  • Data integrity has become a major challenge but also a chance for modernization and optimization. To comply with expectations and regulations, companies need to analyze their overall GMP data management, system landscape and related GMP data flows. The following article outlines a basic data-flow oriented approach for such data assessments, as well as considerations for …
  • Auszug aus dem GMP-BERATER Dokumentation ist ein wesentlicher Bestandteil des pharmazeutischen Qualitätssystems. Sie spielt in jeder Phase des Lebenszyklus eines Arzneimittels eine wichtige Rolle, denn die Qualität eines pharmazeutischen Produktes muss zweifelsfrei nachweisbar sein! Deshalb ist es kaum verwunderlich, dass viele Verantwortliche aus dem Pharmabereich mit einer wahren Flut an Daten und Dokumenten kämpfen müssen. …