ISPE Milan Conferences - Kereon AG

Infrastructure: Validation, Compliance and Control in
30 November 2005
Conference Leaders
Sandro De Caris, IT Compliance Consultant, Italy
Hasse Greiner, Novo Nordisk A/S, Denmark
Conference Description
During this course, delegates will be presented with a
complimentary copy of ISPE’s new GAMP ®
Good
Practice Guide: IT Infrastructure Control and Compliance.
The new Guide facilitates global applications and
services, enabling the corporation to operate and
communicate safely across internal and external
borders.
The course focuses on the dynamic nature of an
infrastructure and discusses the processes and types of
technology deployed with emphasis on achieving and
maintaining control and compliance, taking advantage
of the overall risk level and widespread control
technology available.
Who Should Attend
• Platform managers, infrastructure process managers,
subject matter experts
• Information system managers
• Technology managers
• IT/IS validation and quality assurance subject matter
experts
ST
Simultaneous translation (English-Italian), is sponsored by
La traduzione simultanea è sponsorizzata da
The course discusses management processes for
servers, clients and networks and the way they affect an
organisation’s choice of strategies for operation,
security, compliance and control as well as the various
roles and responsibilities of the people involved.
Programme
Learning Objectives
At the conclusion of this conference, delegates will be able to:
• Identify the infrastructure key elements: processes,
platforms and people
• Understand and use the terminology and main
compliance concepts
• Understand infrastructure processes and their role in
achieving and maintaining compliance
• See the infrastructure control and compliance
challenges from a regulatory standpoint
• Pinpoint the important aspects of platform
qualification and management: servers, clients,
networks
• Embrace system and infrastructure security
concerns: user access controls, platform hardening,
fire walling, patch management
• Avoid pitfalls in the allocation of roles and
responsibilities: system, platform and infrastructure
process owners, administrators, subject matter
experts, QA
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