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A Risk Based Approach To IT Infrastructure Qualification & Compliance ntz







A Risk-Based Approach To IT Infrastructure Qualification & Compliance (ntz)
For more information: https://www.eventbrite.com/e/certified-ethical-hacker-v10-ceh-ec1-tickets-52286175358

DESCRIPTION
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GxP Regulated companies are dependent on validated GxP computerized applications to conduct their day to day operations. These applications are, in turn, depended upon a qualified infrastructure that can be relied upon to provide control and regulatory compliance.

The consequences of the IT Infrastructure being out of compliance can result in the failure of an entire site or geographic region being brought to a standstill while the compliance issue is resolved.

Effective IT Infrastructure Qualification on the other hand, confers the following benefits.
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Ensures GxP compliance
Reduces duplication of effort
Ensures adherence to standards
Enhances the flow of information throughout an information system
Promotes adaptability and agility necessary for a changeable environment
Ensures interoperability among organizational and external entities
Maintains effective change management policies and practices
Although all business activities depend upon the infrastructure, planning and projects to ensure its effective management are typically undervalued to the detriment of the organization.

For more information: https://www.eventbrite.com/e/certified-ethical-hacker-v10-ceh-ec1-tickets-52286175358

Establishment and maintenance of a controlled infrastructure require that infrastructure needs to be brought into initial compliance with the company’s established standards, through a planned qualification process, based upon domestic and international best practices and standards. The qualification needs to be documented and confirmed by Quality Assurance.

The Seminar:
This Seminar provides a risk-based approach to meeting current regulatory expectations for compliant IT Infrastructure platforms, including the need to identify, qualify and control those aspects impacted by GxP quality and data integrity.

This Seminar focuses on the horizontal approach to IT Infrastructure Qualification which includes the following benefits:

Higher level of standardization throughout the entire lifecycle
Minimal overlap in documentation
Minimal overlap in qualification
Minimal overlap in audits inspections and assessments

The areas addressed by the seminar include:
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How does IT Infrastructure Qualification fit into GaMP5 lifecycle
Quality Management for Infrastructure
Risk management for Infrastructure Qualification
Installation & Operational Qualification of Infrastructure Componenets
Configuration management and change control of infrastructure components and settings in a highly dynamic environment
Involvement of service provider in critical infrastructure processes
Security management in relation to access controls, availability of services and data integrity
Backup, restore and disaster recovery of IT Infrastructure

Why you should attend:
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VP of IT
Director of IT
Quality Managers
Project Managers (for CSV / IT)
Validation Specialists
Database Administrators
System Administrators
Directors / Senior Directors of Discovery
Directors / Senior Directors of Development
Directors / Senior Directors of Commercialization
Document Managers
Training Managers
Regulators
Vendors
Suppliers
Outsource Service Providers
Industries:
Pharmaceuticals
Biotech
Medical Device
Radiological Health
Blood Products
Companion Animals
Food
Cosmetics
Tobacco
Academia

Angela Bazigos
CEO, Touchstone Technologies Silicon Valley
Seasoned Executive with 40 years of experience in the Life Sciences & Healthcare Industries. Positions include Chief Compliance Officer http://morflearning.com/angelabazigos/.

Please contact the event manager Marilyn below for the following:
– Discounts for registering 5 or more participants.
– If your company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
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For more information: https://www.eventbrite.com/e/certified-ethical-hacker-v10-ceh-ec1-tickets-52286175358

Eventbrite: https://www.eventbrite.com/o/event-promotions-by-new-york-events-list-11118815675
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