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Information for registration to this event will follow soon: Event: 2. Ulmer Qualitätsmanagementforum Das moderne QM-System – Risikobasierte Ansätze – Theorie und Praxis 20. Juli 2012 ab 10:00 Uhr im Ludwig-Erhard-Saal, IHK Ulm By the cluster . . . → Read More: SAVE-THE-DATE: BioPharMaXX – 2. Ulmer QM-Forum – 20. July 2012 US-FDA CDER offers following training courses online. World of Compliance (October 20, 2011) Course Outline: Lesson 1: Office of Compliance Overview World of Generic Drugs (October 20, 2011) Course Outline: Lesson . . . → Read More: US-FDA: Training and Continuing Education – CDER World Interview by BioPro – Markus Roemer – towards paperless production: Read the interview in English here: OPEN Read the interview in German here: OPEN The Biotech / Life Sciences Portal Baden-Württemberg is run by BIOPRO Baden-Württemberg GmbH. Working in close cooperation with our authors from the Rhine-Neckar Triangle, STERN, Freiburg, Ulm and BioLAGO bioregions, we . . . → Read More: Pharma 2.0: towards paperless production – Interview by BioPro – Baden Württemberg Stay updated with our CCS Android App: Download Installation: Right-click on the download link “save target as” - save and unzip the file on your PC, transfer and install it on your Android SmartPhone. You will automatically receive current news and information from CCS services, events, and news including our validation . . . → Read More: Stay updated with our CCS Android App – Install it now…
MS SharePoint webinar – 16th April at 14:30-15:30 GMT – open link for registration: GXPI eshot ‘Great – It’s Another Webinar’ 280312 examine the setup, management and consumption of documents supporting a PQS (Pharmaceutical Quality System) according ICH Q10. Our latest recommendation: How to find and setup a shared audit with other companies and QPs? At our CCS Audit Service Center we do reference to the “QPSHARE” database, which is provided to the members of the European QP Association (external link). The European QP Association initiated a database comprising shared audits information between Qualified Persons. In a first step QP . . . → Read More: Shared Audit Setup with QPShare comes compliance services joined the MESA International organisation: MESA (Manufacturing Enterprise Solutions Association) International is a global community of manufacturers, producers, industry leaders and solution providers who are focused on improving Operations Management capabilities through the effective application of technology solutions and best . . . → Read More: CCS joins MESA.org as member German Translation Annex 11 – Deutsche Übersetzung Anhang 11 – Revision 2011 by zlg.de – EFG 11: Download: EU_GMP_Leitfaden_Anhang_11_DE_v2 (Annex 11 – Deutsch) Download: EFG_votum V11003 (Anforderungen an elektronische Unterschriften und Handzeichen) Contact us for more information, gap assessments, front-end studies . . . → Read More: German Translation Annex 11 – Deutsche Übersetzung Anhang 11 – Revision 2011 CCS membership at bwcon 2011: Baden-Württemberg connected – Read more… Baden-Württemberg: Connected e.V., or bwcon for short, is the top business initiative promoting Baden-Württemberg as a high-tech location. As one of the most successful European technology networks, bwcon connects more than 460 companies and research institutes. Currently more than 4,600 experts are benefiting from systematic networking via . . . → Read More: bwcon 2011: CCS networking GMP Verlag published the new ‘GMP Paperback CSV’ in July 2011, written by Markus Roemer. It contains a current view on Annex 11 – Revision 2011, basic requirements of ISPE GAMP 5, quality risk management, and up-to-date validation strategies and special topics (e.g. ERP, Excel, data migration, and much more). Read more: GMP LogFile #9 from July 2011 (German) This . . . → Read More: GMP Paperback Computer System Validation Revision 2011 |
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