q&more
My watch list
my.chemie.de  
Login  

Event

A Risk Based Approach To IT Infrastructure Qualification & Compliance

in Bloomington from 24-May-2018 - 25-May-2018

Description:
Course "A Risk Based Approach To IT Infrastructure Qualification & Compliance" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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
• Regulators
• Vendors
• Suppliers
• Outsource Service Providers
________________________________________
Industries:
• Pharmaceuticals
• Biotech
• Medical Device
• Radiological Health
• Blood Products
• Companion Animals
• Food
• Cosmetics
• Tobacco
• Academia
Agenda:
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
• SOPs
• Training
• Audits
________________________________________
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
• Planning
• Specification & Design
• Exercise
Day 2 Schedule
________________________________________
Lecture 5:
Qualification of Platforms (cont'd)
• Procurement
• IQ, OQ, PQ
• Reporting
• Handover
• Exercise
________________________________________
Lecture 6:
Operations
• 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
Speaker:
Angela Bazigos
CEO, Touchstone Technologies Silicon Valley

Type of Event: Courses
Event Date: 24-May-2018 to 25-May-2018
Event Location: Embassy Suites Minneapolis - Airport
Bloomington
USA
Language: English
Attendance Fee: $1,295.00 
Deadline: 24-May-2018
Event Organiser: Netzealous - GlobalCompliancePanel
Topics:

Topics A-Z

All topics

q&more – the networking platform for quality excellence in lab and process

The q&more concept is to increase the visibility of recent research and innovative solutions, and support the exchange of knowledge. In the broad spectrum of subjects covered, the focus is on achieving maximum quality in highly innovative sectors. As a modern knowledge platform, q&more offers market participants one-of-a-kind networking opportunities. Cutting-edge research is presented by authors of international repute. Attractively presented in a high-quality context, and published in German and English, the original articles introduce new concepts and highlight unconventional solution strategies.

> more about q&more

q&more is supported by:



Your browser is not current. Microsoft Internet Explorer 6.0 does not support some functions on Chemie.DE