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 for your company.
Background
Virtual IT 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
Principles of IT qualification and validation
Regulatory requirements
Definitions
Validation and qualification
What is Virtualisation?
Definitions
Physical platform foundation requirements
Software for virtualisation
Virtual platform options
Benefits of Virtualisation
On demand infrastructure
Speed of implementation
Flexibility
Regulations apply to Virtualisation
Annex 11 key points for consideration
IT infrastructure shall be qualified
In-house or hosted system
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
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
Compliance requirements for virtual systems
IT Infrastructure Platform
Server Platform Qualification
Virtual Platform considerations
Maintaining the Qualified State during operation
Overview of the virtualisation platform
Platform components
Platform operation
Handling of SANs and VMs
Qualification of the virtualisation platform
Requirements gathering
Platform design
Qualification planning
Supporting processes
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
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
Virtualisation of laboratory equipment / Desktop virtualisation
Use cases for virtualisation in a laboratory environment
Operating a virtual system
Show and tell: Virtualisation documentation
Technical Requirements Specification
Configuration Specifications
Installation Qualification
Change & Configuration Management
Regulatory requirements
What is a change?
Definitions of change management & configuration management
An outline change management process
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
This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager" Learn more
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