CCS joins MESA.org as member

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

ISPE DACH Affiliate event: 21. / 22. November 2011

Meet us at the ISPE DACH Affiliate Event (21. / 22. November 2011) in Biberach, . . . → Read More: ISPE DACH Affiliate event: 21. / 22. November 2011

“UNI meets Pharma 2011″ Event Sponsor

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:

Web: BioLago e.V.
Event Brochure 2011 

When: Monday, 19. September 2011; 15.30 Uhr
Where: . . . → Read More: “UNI meets Pharma 2011″ Event Sponsor

Pharma 2.0 – PTS Training – 13.& 14. September 2011 in Wiesbaden, Germany

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 . . . → Read More: Pharma 2.0 – PTS Training – 13.& 14. September 2011 in Wiesbaden, Germany

CCS at GMP and Technology Conference 2011

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

Computervalidierung, elektronische Dokumentation:
Annex 11 und Kapitel 4 EU-GMP-Leitfaden
Markus Roemer, ccs comes . . . → Read More: CCS at GMP and Technology Conference 2011

The Evolution of Electronic Document Management Systems by GxPi

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 . . . → Read More: The Evolution of Electronic Document Management Systems by GxPi

CCS event sponsoring of bwcon: Fachforum “Auf dem Weg zur Personalisierten Medizin – Herausforderungen und Potenziale für die IT”

comes compliance services is sponsoring the bwcon (Baden-Württemberg: Connected ) event for personalized IT medicines.

When: 17. March 2011, 10:00 – 16:15

Where: Nycomed, Byk-Gulden-Str. 2, 78467 Konstanz, Germany

Join us: More information (in German) and how to join the event: OPEN LINK

when IT comes to compliance…
comes . . . → Read More: CCS event sponsoring of bwcon: Fachforum “Auf dem Weg zur Personalisierten Medizin – Herausforderungen und Potenziale für die IT”

NEW ANNEX 11 – Computerised Systems – revision January 2011 – CCS solution package

EMA published today the new GMP Annex 11 – Computerised Systems – revision January 2011 – download your copy here: PDF 

The deadline for coming into operation of the new Annex 11 is 30th June 2011. 

Find here also the new EudraLex Chapter 4 – Documentation: PDF
Report “New Annex 11″ in German from the GMP Verlag:  Info

Basic Principle of . . . → Read More: NEW ANNEX 11 – Computerised Systems – revision January 2011 – CCS solution package

CCS lecture at the University of Albstadt Sigmaringen

CCS was giving a lecture at the Hochschule Albstadt Sigmaringen (University – pharmaceutical Technology). Mr. Markus Roemer was giving to the students an overview of different aspects of Pharma 2.0 methods and current industry thinking & approaches.

The implementation of electronic systems, which are using electronic signatures, e.g. for batch recording, lab management, eCTD, and document management systems, require . . . → Read More: CCS lecture at the University of Albstadt Sigmaringen

CCS sponsored the PDA Europe Conference – Parenterals 2010

comes compliance services was sponsoring the PDA Event:

PDA Europe Conference – Parenterals 2010 – Integrating Process, Technology and Regulation, 26-28 October 2010 in Berlin, Germany.

The visitors’ feedback of the conference was very positive – excellent speakers, good speach topics, well organized, opportunity to exchange information and ideas.

Feel free to contact us today at talk@comes-compliance.com  for more information . . . → Read More: CCS sponsored the PDA Europe Conference – Parenterals 2010