IT / OT Infrastructure - Qualification and Operation in a GMP Environment - Online Training Recording
Course No. 19570A
Speakers
Dr. Bob McDowall
R.D. McDowall Ltd.
Yves Samson
Kereon
Frank Behnisch
CSL Behring
Objectives
Get an overview of technologies discussed currently in the pharmaceutical environment
Learn what requirements are placed on the IT infrastructure and its qualification within the scope of GMP regulations
Principles outlined can be applied to Operation Technology (OT) for production systems
IT security and cybersecurity has now taken on a central role; here you will learn about the importance of the IT infrastructure in terms of an appropriate IT security concept
Case studies show you qualification approaches for key IT infrastructure components
Virtualization is a part of the IT infrastructure; learn strategies for qualifying the virtual machine and the virtualization platform
Background
In today’s pharmaceutical environment, the IT infrastructure is the backbone for the application of a wide range of software solutions. The requirements for IT security are becoming increasingly important. Only a robust IT infrastructure with suitable network topologies and security concepts can guarantee the appropriate security here.
Pharmaceutical regulations contain few or only indirect requirements for the IT infrastructure. The principles of the EU GMP guidelines state “The application should be validated, the IT infrastructure should be qualified”. Here the phrase “should” corresponds to a “must”! Further information can be found in the revised version of the GAMP® Good Practice Guide “IT Infrastructure Control and Compliance” published in August 2017.
Target Group
The Online Training is aimed at managers from the pharmaceutical industry, suppliers and service companies who plan, qualify and operate IT infrastructure in a GxP Environment.
Technical Requirements
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Please be aware: The recording does not include the Q & A sessions.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Programme
IT/OT Infrastructure Model
Overall IT/OT infrastructure enterprise model
GAMP IT infrastructure model
Applying GAMP software categories
OT specifics
Applicable to all options: on premise / data hotel / SaaS IT
Regulatory and Legal Requirements / Agreement for IT/OT infrastructure
GxP regulations with focus on Annex 11 and Chapter 7
Supplier assessment and agreements for IT suppliers
Risk management
Quality and technical agreements and service levels
Governance and Quality oversight
Time synchronisation
Brief summary of legal requirements
e.g. GDPR, HIPAA, etc.
Effective and Efficient Compliance
Supporting life cycle model
Specification
Design
Verification
Security and Cybersecurity for a Robust IT/OT Infrastructure
IT infrastructure security requirements
Cybersecurity: ransomware and malware
Sizing / Availability / Reliability
Basic security rules
Network topology
Network segregation
IT infrastructure monitoring
Recommendation for data archiving support
PEN testing
Planning Virtualisation Projects
User / Technical Requirements Specification
Definition of the installation and deployment approach
Risk management
Definition of backup cycles and scenarios
Efficient planning
Qualification planning
Life cycle of virtual environment
Differences between virtual, physical, and as-a-Service installation and deployment
Virtualisation Platform: Overview
Platform operation
SANs and VMs handling
RAID technology
Qualification of the Virtualisation Platform
Platform design
Requirements and constraints
Data management
Disaster recovery
Qualification planning
Specifications
Verifications
Qualification Documentation
QP – Qualification Plan
TRS – Technical Requirements Specification
CS – Configuration Specifications
IQ – Installation Qualification a.k.a. Configuration Testing
Design Review of IT Infrastructure
Design Review and Risk Management purpose
Performing Design Review
What might go wrong?
Critical review of the IT infrastructure
Design and monitoring of mitigation measures
Case Study: Firewall Qualification
Requirements
Purpose
Operation
Risk assessment
Configuration specification
Definition of the security rules
Operating parameters
Configuration Testing (IQ)
Functional Testing (OQ)
Operation
Monitoring
Change & Configuration Management
Incident Management
Disaster Recovery Planning
Regulatory requirements for disaster recovery
For virtual and physical environment
Disaster recovery or business continuity plans?
Disaster recovery plan and testing
Order of application recovery with associated data
RPO – Recovery Point Objective
RTO – Recovery Time Objective
Case Study: Central Backup Management System
Requirements
Verification
Risk assessment
Configuration specification
Server / Agent / Operating parameters
Configuration Testing (IQ)
Functional Testing (OQ)
Supporting SOPs
System management
Backup / Restore
Disaster Recovery
Operation
Incident and Problem Management
Definition of incident and problem
Incident investigation
Collating incidents into problems and their resolution
Linking with change control
Infrastructure as a Platform for Various Applications
Definition of Platform
Generic approach
Standard changes
Infrastructure lifecycle challenges for applications & GxP
Specialties in automation – challenge for infrastructure in 24/7 real-time applications
Change and Configuration Management
Regulatory requirements
Definitions of change control and configuration management
Outline of a change management process
Agile Infrastructure: Introduction to Infrastructure as Code (IaC)
Definition & scope
Toys or tool?
40 years evolution
Flexibility & Agility
From installation to provisioning
The costs of Agility
Rigorous planning
Adequate tools
Training
Risks and Benefits
Recording from 23/24 June 2022 Duration of the recording: approx. 11 h 23 min
This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager" Learn more
Testimonials