Current Regulatory Expectations for Compliant IT Infrastructure Platforms
Course
In Boston (USA)
*Indicative price
Original amount in USD:
$ 1,495
Description
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Type
Seminar
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Location
Boston (USA)
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Class hours
9h
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Duration
2 Days
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.
Facilities
Location
Start date
Start date
About this course
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 Components
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
Scope:
This seminar addresses compliance with international GxP regulations and considers:
The establishment of new platforms and extensions to existing ones
Existing platforms already in support of GxP applications
Current GxP requirements related to IT infrastructure platforms have been taken into account including:
Good Manufacturing Practice (GMP)
Good Clinical Practice (GCP)
Good Laboratory Practice (GLP)
Good Distribution Practice (GDP)
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
Reviews
Subjects
- Risk
- Compliance
- Approach
- Design
- IT risk
- Pharma
- Medical Science
- Regulatory
- Fda
- FDA perspective
Teachers and trainers (1)
Angela Bazigos
CEO, Touchstone Technologies Silicon Valley
Course programme
Introduction and Background
- Introductions / Participants’ Understanding / Participants’ Objectives for the Course (Please come prepared to discuss)
- 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)
Infrastructure Options - Non-Cloud
- Infrastructure Services
- Platforms
- Processes
- Personnel
Infrastructure Options - Cloud
- Current Concepts & Challenges in Cloud Computing
- Cloud Computing in a GxP Environment: The Promise, the Reality and the Path to Clarity
- IaaS Cloud in Regulated LifeSciences companies
- A Risk Based Perspective on Leveraging PaaS within a Regulated LifeSciences Company
- Using SaaS in a Regulated Environment – A LifeCycle Approach to Risk Management
- SaaS in a Regulated Environment – The Impact of Multi-Tenancy and Subcontracting
- Determine Regulated Cloud Strategy at Your Company by Answering 5 Key Questions
Risk Management
- Assessment of Risk Components
- Implementation of Mitigation and Controls
- Change Control to Qualified Components
- Periodic Review
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)
- Exercise
- Procurement
- Supplier Evaluation
- Installation & IQ
- Verification of Documentation
- Environmental Conditions
- Servers
- Clients
- Networks
- OQ & Acceptance
- Reporting
- Handover
- Exercise
Principles & Best Practices for Qualifying Cloud Infrastructure
- Understanding Cloud Infrastructure Qualification Principles
- What do Regulators Want
- How Do You Qualify the Cloud?
- Best Practices for Successful Validation
- Bonus:
- Cybersecurity Assessment
- Sample Cloud SOPs for Governance
Operations
- Security Management
- Upgrade & Patch Management
- Server Management
- Performance Monitoring
- Client Management
- Network Management
- Problem Management
- Help Desk
- Outsourcing & Supplier Management
Maintaining the Qualified State
- Change Management
- Configuration Management
- Backup, Restore & Archiving
- Disaster Recovery of IT Infrastructure
Quiz: Jeopardy!!!!
- IT Infrastructure Qualification & Compliance
Current Regulatory Expectations for Compliant IT Infrastructure Platforms
*Indicative price
Original amount in USD:
$ 1,495