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.
The
impact of such compliance issues on a regulated company can be
significant: it can result in recalls of products, warning or untitled
letters, import alerts, injunctions, seizures, legal action, etc. These
regulatory actions can have significant financial impact to the company.
However, and most importantly, data integrity issues can lead to
potential patient harm!!
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
Why you should attend
This Virtual
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. 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
Virtual 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
Areas Covered in the Session
- How does IT Infrastructure Qualification fit into GaMP5 lifecycle
- Quality Management for Infrastructure
- Risk management for Infrastructure Qualification
- Installation & Operational Qualification of Infrastructure Components
- Change control of infrastructure components and settings in a highly dynamic environment
- Involvement of service provider in critical infrastructure processes
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
- Regulators
- Vendors
- Suppliers
- Outsource Service Providers
Angela Bazigos is the CEO
of Touchstone Technologies Inc. She has degrees in Microbiology and
Computing and 40 years of experience in the Life Sciences, Healthcare
& Public Health Services.
Experience
combines Quality Assurance, Regulatory Compliance, Business
Administration, Information Technology, Project Management, Clinical Lab
Science, Microbiology, Food Safety & Turnarounds. Past employers /
clients include Royal Berkshire Hospital, Roche, Novartis, Genentech,
PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief
Compliance Officer,Director of QA and MIS Director. Co-authored &
prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems
in Clinical Research w/ FDA & DIA Patent on speeding up software
compliance https://www.google.com/patents/US8266578.
Recently
quoted in Wall Street Journal for using training to bring regulatory
compliance to the Boardroom includes training 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.
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Time: 08:00 AM PDT | 11:00 AM EDTModule 1: Introduction and Background
- Infrastructure Qualification and the GaMP5 Lifecycle
- Key Concepts
- Platforms to run the business applications (e.g. CDMS, IVRS, LIMS, ERP)
- IT Infrastructure processes that facilitate a capable & controlled IT environment
- General IT services (e.g. email system, office tools, intranet facilities, file storage)
Module 2: Infrastructure Options
- Infrastructure Services
- Platforms
- Processes
- Personnel
Module 3: Risk Management
- Assessment of Risk Components
- Implementation of Mitigation and Controls
- Change Control to Qualified Components
- Periodic Review
Module 4: Qualification of Platforms
- Overview of Process
- IT Infrastructure LifeCycle
- Planning phase
- Specification & Design phase
- Risk Assessment & Qualification test planning phase
- Procurement, installation and IQ phase
- QA & acceptance phase
- Operation & maintenance phase
- Retirement (decommissioning / withdrawal phase)
- Procurement
- Supplier Evaluation
- Installation & IQ
- Verification of Documentation
- Environmental Conditions
- Servers
- Clients
- Networks
- OQ & Acceptance
- Reporting
- Handover
Venue
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