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      A Risk Based Approach To IT Infrastructure Qualification & Compliance (NTZ) in Revere

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      June 14, 2018

      Thursday   9:00 AM - 6:00 PM

      Revere 407 Squire Road
      Revere, Massachusetts 02151

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


      A Risk Based Approach To IT Infrastructure Qualification & Compliance


      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

      Who will benefit:

      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)

      IQ, OQ, PQ

      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


      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:
      - Multiple participant discounts
      - Price quotations or visa invitation letters
      - Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)
      - Event sponsorships

      Service fees included in this listing.
      This event is brought to you by:
      NETZEALOUS LLC - NewYorkEventsList


      Cost: Free - $1,485 – $8,212

      Categories: Conferences & Tradeshows

      Event details may change at any time, always check with the event organizer when planning to attend this event or purchase tickets.
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