Virtual IT-Systems in a GxP Environment

Virtual IT-Systems in a GxP Environment

Berlin, Germany

Course No 9265


Costs

This conference already took place.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Bob McDowall, McDowall Consulting
Yves Samson, Kereon AG
Jürgen Schmitz, Novartis Vaccines and Diagnostics

Objectives

Get an overview of technologies discussed currently in the pharmaceutical environment and their potential fields of application,
Assess how to use and implement GMP requirements and provisions for virtual IT systems and, where appropriate, for cloud computing,
Learn more about the qualification and use of virtual systems in the GMP environment, and
Evaluate whether the use of virtual IT systems and cloud computing would be profitable if your company.

Background

Virtual systems, cloud computing, and GMP; does this fit together? What are the advantages and disadvantages of these systems in a GMP environment? Are there any limits with their use?

The increasing use of virtual IT systems and cloud computing in a GMP regulated environment is getting more and more discussed. The virtualisation of computer systems offers a great number of advantages, such as the simultaneous use of multiple operating systems, the simple and low-cost construction of test environments, and the improved utilisation of multi-core processors.

Can these advantages also be used in a GMP environment and which aspects have to be specifically considered from
the “GMP view” for virtual systems and cloud computing?

This event considers virtual systems and cloud computing from the GMP point of view and provides practical
support to determine measures regarding the use of
such systems.

Target Group

The event is aimed at managers in the pharmaceutical industry, suppliers and service providers that operate virtual IT systems and cloud computing in a GMP environment or intend to use them in the future

Programme

IT Infrastructure in a GxP Environment
Regulatory requirements
Definitions
Validation and qualification


Workshop: Qualification Documentation
Designing reusable documentation for virtual systems
Key requirements for reusable qualification documents

Workshop:
Planning of Virtualisation Platform
What is Virtualisation?
Definitions
Physical platform foundation requirements
Software for virtualisation
Virtual platform options

Compliance Requirements for Virtual Systems
IT infrastructure platform
Server platform qualification
Virtual Platform considerations
Maintaining the qualified state during operation

Planning of Virtualisation Projects
User / Technical Requirements Specification
Definition of the installation and deployment
approach
Definition of backup cycles and scenarios
From a virtual server to a virtual farm
Efficient planning
Qualification planning

Qualification of IT-Infrastructure
General Principles of IT Infrastructure Qualification
How to do qualification in a real environment vs. what to do in a virtual environment
Qualification Activities
Roles and responsibilities
Installation and Testing

Risk Management
ASTM E 2500-07
Good Engineering Practice (GEP)
Q 9 – Quality risk management
GAMP 5, M 3
GEP, Qualification, Validation reconciliation
NIST-SP 800-30 Risk Management for IT systems
HA-Op

Making of a Virtual Data Centre
Specification of virtual data centre requirements
Do I qualify or validate the hypervisor software?
Building and qualifying a virtual data centre

Virtualisation of Laboratory Equipment /
Desktop Virtualisation
Use cases for virtualisation in a laboratory
environment
Operating a virtual system

Disaster Recovery Planning
Regulatory requirements for disaster recovery
Disaster recovery or business continuity planning?
Mitigating physical faults
Triggers for the plan
Testing the plan
Keeping the plan up to date

From Virtualisation to Cloud Computing
What is cloud computing really?
Abstraction of services and IT infrastructure
Virtualisation vs. cloud computing
Recommendations for a GxP-compliant cloud computing

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