Open the Flyer 2 QM-Forum Web_final for more information and registration.
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 of BioPharMaXX.
Event is based on PIC/S: pi-038-1-aide-memoire-on-assessment-of-qrm-implementation (2012)
Special Trainings 2012 – compliance and computer system validation by PTS:
CCS provides compliance training & best practice knowledge on EU and FDA guidelines, regulatory compliance, regulations, standards, and methods. Meet us there.
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 present the highlights of Baden-Württemberg research, the products and developments of Baden-Württemberg companies as well as articles of general interest from the life sciences area. The portal, which is updated on a weekly basis, also provides general information on the region.
comes compliance services is member of the BioLAGO e.V. network – www.biolago.org.
GxPi works upon the principal that complex issues can be simplified to deliver long term business benefit, better efficiencies and cultural change. We achieve this through a combination of products and services designed specifically for compliance requirements in the life sciences sector. GxPi’s products, x-docs™ and x-train™, provide enterprise grade electronic Document, Content and Compliant training solutions. GxPi’s services cover all aspects of regulatory compliance (GMP, GAMP, GLP, GEP, GCP, GDP), qualified person (QP), quality assurance (QA), and validation particularly with Computerised and Information Technology (IT) systems. (For more information, please visit www.gxpi.com )
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 practices.
Meet us at the ISPE DACH Affiliate Event (21. / 22. November 2011) in Biberach, Germany.
CCS is sponsoring the Event “UNI meets Pharma” in Konstanz, Germany. This is the third time that the event will be hosted in Konstanz at the University and organized by BioLAGO. These events always offer good opportunities to meet interesting people with different backgrounds and to network.
Find more information:
When: Monday, 19. September 2011; 15.30 Uhr
Where: Universität Konstanz, Hörsaal R 513
Or contact us directly at: talk@comes-services.com
Go and visit the PTS Training event “Pharma 2.0”:
– Electronic Batch Recording
– Document Management and Control (eDMS)
– Data Warehouse and Management
– IT Service Management
– Paperless Lab
– eValidation and Test Management
– eCTD and GCP solutions
– new regulatory requirements (EU Annex 11, US-FDA 21 CFR Part 11)
Event details: 20. -21. October 2011 in Freiburg / Germany.
Download the conference brochure here.
Contact us at talk@comes-compliance.com for more details.
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Session 6. Neuerungen im GMP Umfeld / Autorenwissen – Live
Moderation: Anita Maas, Maas & Peither AG, Dr. Maria Brecht, PTS Training Service
How systems can support compliance in a regulated environment:
The webinar will consider the evolution in the development and delivery of compliance related document management systems using the challenges of managing Quality Management System (QMS) documents. It will look at the advantages of using documents in a SharePoint environment for working examples.
Over the last decade, the requirements of organisations around the implementation of compliance related systems have evolved, which has significantly changed the relationship between the people, process and technology.
The tendency now in the experienced organisations (those where EDM is in its 2nd or 3rd generation) is to implement a configurable platform, providing a set of functionality to support the users but not to make the system wholly responsible but operate in conjunction with the working processes and the decisions made by the users themselves. This change can be loosely described as a rebalancing of the people-process-technology triangle, which is often used to describe the implementation of systems.
This evolution has resulted in advantages in terms of usability, acceptability and reduced total cost of ownership in ensuring GxP compliance. READ MORE
23 March 2011 at 15:00 GMT
contact: atoepsch@gxpi.de
