Charles Munk
IT Consultant, AABB Advancing Transfusion and Cellular Therapies Worldwide
Goals:
- Manage strategic and operational projects where IT/IS are involved
- Support IT governance/management with appropriate management and security standards
- Support business processes with appropriated use of IT solutions
- Provide support on validation for system implementation (GAMP)
- Stimulate interdisciplinary collaboration and communication for getting the most of IT/IS
Knowhow:
Languages: French (mother tongue), English (fluent), German (intermediate)
Regulations and standards: GMP, EU, FDA, ISO, GAMP 5, ITIL V3, CobiT, PRINCE2, ISBT 128
Architecture of Information, Information System and IT infrastructure
Key publications and presentations on issues related to the benefit in using standards for managing information technology
Interest:
- Quality Management and the use of IT/IS
- Project management
- Validation of IT/IS and automated systems
- Information Security
- Role of Information in an Organization
- Management of Information Technology
- Green IT
13 contactsTraining, coaching and coordination of projects and validation activities related to IT in developing countries
=> Developping Business cases/Feasability study
=> Training & Consulting on Validation and IT Management / Governance according to standards and regulation
=> Managing IT Project & Validation Process
2006 - 2009=> IT Director : Management of the IT Team
=> Supervision of the implementation of ITIL processes
=> Optimization of IS and the IT infrastructure on multiple sites
=> Leading the project including validation activities aiming at merging 3 organization ERP systems on a unique platform
2001 - 2007=> 2001 – 2007 : President of the Working Party on Information Technology
Coordination of Task Forces for Validation, Information Security, RFID and Standard Interfaces
=> 2004 – 2006 : Co-president of the Information Security Task Force
Publication of Guidelines on Information Security (ref. ISO 17799, HIPAA)
=> 2000 – 2004 : President of the Validation Task Force
Publication of Guidelines on Validation (ref. GAMP 4, PIC/s & FDA guidances)
2000 - 2003Implementation of the ISBT 128 standard for the blood and blood products’ identification on a national basis
1995 - 2005=> Member of the board
=> Participation in the ISO 9001:2000 certification process
=> Leading the Technical & IT Service
=> Implementing a validation policy
=> Managing equipments, IT infrastructures and the ERP system
=> Leading key projects and validation activities related to IT/IS, ERP and automated systems
=> Contract with the Wallis Blood Transfusion Service for management projects and support related to the ERP system
1990 - 1995Development of a Rapid Prototyping Environment as well as a Common Specification Intermediate Format in C++ under UNIX Solaris
1989 - 1990Conception of a data acquisition and management system for combined drawing machines used in the steel industry