Category: CCS news

Current Newsletters at BIOPRO:

• Member CCS joined BioLago e.V. (EN)
• Member CCS joinde BioLago e.V. (DE)
• Ernst & Young: “German Biotechnology Report 2010”

Baden-Württemberg is the most innovative region in Europe. The figures for 2008 show that 4.2 percent of the gross domestic product is being invested in research and development. With its versatile, outstandingly efficient research in biotechnology and the life sciences, Baden-Württemberg has a unique trump card in terms of the economic development of the life sciences in the state.

CCS is located in the south of Germany, Ravensburg: More

The Biotech / Life Sciences Portal Baden-Württemberg is run by BIOPRO Baden-Württemberg GmbH.

CCS provides risk-based and compliant Validation and Qualification Services based on current regulations and standards. The German ZLG (central autority for helth protection) issed a new  Aide mémoire 07121105 “Inspektion von Qualifizierung und Validierung in pharmazeutischer Herstellung und Qualitätskontrolle”.

Read more here.

Contact CCS for more information: talk@comes-compliance.com

Portfolio, Programme and Project Management Maturity Model (P3M3) used in compliance project.

P3M3 uses a five-level maturity framework and the five Maturity Levels are:

Level 1 – awareness of process

Level 2 – repeatable process

Level 3 – defined process

Level 4 – managed process

Level 5 – optimized process

 

BioLago News (German): http://www.biolago.org/aktuelles-presse/news-artikel/experte-in-healthcare-life-science-neu-mitglied-comes-compliance-services-bereichert-biolago-netzwerk/

 

New CCS network partner in US / Canada:
RxGlobal Consulting Solutions Inc.;

 

Rx GLOBAL is an innovative life science consulting company that is rapidly increasing market share by providing competitive, common sense regulatory compliance consulting solutions for our client’s business challenges. Based in North America with Associate Partners in Europe and Asia, our team of seasoned, industry leading professionals provide the hands on expertise that will drive value throughout the full solution delivery lifecycle. Rx GLOBAL utilizes a flexible approach to define custom consulting solutions that exactly meet the project support needs and expectations of our international client base.

Our knowledge and expertise is rooted in successful compliance and validation project delivery, however, the vast experience of our consultants allow us to move past this core solution space into the definition and delivery of business process improvement and strategic corporate initiatives. For details on how Rx GLOBAL can assist your team in reducing project delivery timelines and costs, contact us at: information@rxglobalcs.com

Web: www.rxglobalcs.com

Read more at: http://www.rxglobalcs.com/partners.html

CCS wins new FDA compliance audit project in Austria, including corrective and preventive actions (CAPA), deviation management, risk and quality management.

CCS wins new global LIMS / Paperless Lab project in Germany.

For more information contact us at:
talk@comes-compliance.com!

CCS provides Auditing Services of several different suppliers and vendors for a pharmaceutical global player in the German speaking area.

ISPE GAMP 5 training: 14th & 15th October 2010, Wiesbaden, Germany, including brand-new Good Practice Guides MES and Operational Management.

30th September 2010: MS Excel Validation

New Focused Solution Package: Network Qualification for small and medium (SME) companies by implementing BSI IT Protection Approach.

Contact now: talk@comes-compliance.com