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.
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
- 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
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)
- Supplier Evaluation
- Installation & IQ
- Verification of Documentation
- Environmental Conditions
- OQ & Acceptance
Ms Angela Bazigos,
Touchstone Technologies Silicon Valley
Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. 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 Life Sciences.
- 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