A Risk Based Approach To IT Infrastructure Qualification & Compliance (ntz)


May 24, 2018 – 9:00 AM - 6:00 PM

7901 34th Avenue South Bloomington
Bloomington, MN 55425 Map

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A Risk Based Approach To IT Infrastructure Qualification & Compliance (ntz)

Thu, May 24, 2018, 9:00 AM –
Fri, May 25, 2018, 6:00 PM

Embassy Suites by Hilton Minneapolis Airport
7901 34th Avenue South
Bloomington, MN 55425
United States


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. It can also result in regulatory citations during a regulatory inspection as both the infrastructure be out of compliance and also cause the computerized applications that are dependent on it to be out of compliance.

Effective IT Infrastructure Qualification on the other hand, confers the following benefits.

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. According to IDC, a prominent research firm (cited in an article in DM Review), investments in infrastructure management have the largest single impact on an organization's revenue.

Establishment and maintenance of a controlled infrastructure requires 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. Once the IT Infrastructure is qualified, the compliant state needs to be maintained by documented standard processes and quality assurance activities. The effectiveness of maintaining the qualified state needs to be monitored and periodically verified.

The Seminar:

This Seminar provide 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. It provides current best practices for the design, qualification and operation of an IT Infrastructure with emphasis on the qualification requirements of the major components. It addresses compliance with international GxP regulations and can be used both for the establishment of new platforms and extensions or existing platforms whether or not they are currently in support of GxP applications. Finally, this seminar covers a range of IT Infrastructures, from those found in companies operating in a global setting to isolated or semi-isolated GxP Infrastructures.

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:

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:

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
Outsource Service Providers
Medical Device
Radiological Health
Blood Products
Companion Animals

Day 1 Schedule
Lecture 1:
Introduction and Background

Introductions / Participants' Understanding / Participants' Objectives for the Course (Please come prepared to discuss)
Infrastructure Qualification and the GaMP5 Lifecycle
Key Concepts
IT Infrastructure Elements
Lecture 2:
Quality Management

Quality Manual
Roles Management
Records Management
Documentation Management
Testing Management
Lecture 3:
Risk Management

Assessment of Risk Components
Implementation of Mitigation and Controls
Change Control to Qualified Components
Periodic Review
Lecture 4:
Qualification of Platforms

IT Infrastructure LifeCycle
Specification & Design

Day 2 Schedule
Lecture 5:
Qualification of Platforms (cont'd)

Lecture 6:

Security Management
Upgrade & Patch Management
Server Management
Performance Monitoring
Lecture 7:
Operations (cont'd)

Client Management
Network Management
Problem Management
Help Desk
Outsourcing & Supplier Management
Lecture 8:
Maintaining the Qualified State

Change Management
Configuration Management
Backup, Restore & Archiving
Disaster Recovery of IT Infrastructure
Quiz: Jeopardy!!!!

IT Infrastructure Qualification & Compliance


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 Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA Patent on speeding up software compliance Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford's Who's Who for LifeSciences:

Please contact the event manager Marilyn (marilyn.b.turner(at) ) below for:
- Discounts for multiple participants.
- Require a price quotation.
- Require to pay by wire transfer or PayPal
- Invitation letter for visa applications

This Event is Brought to You by:
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$1,285 – $7,112

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