CCS News: German ZLG Aide mémoire 07121105 “Inspektion von Qualifizierung und Validierung in pharmazeutischer Herstellung und Qualitätskontrolle”

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

CCS using P3M3 project management for compliance projects

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

New US / Canada Business Partner

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

FDA Inspection Readiness

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

IT Validation Trainings

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