IT / OT Infrastructure Qualification and Operation in a GMP Environment

11-13 June 2025, Copenhagen, Denmark

Course No. 21759

header-image

Speakers

Dr. Bob McDowall

Dr. Bob McDowall

R.D. McDowall Ltd.

Yves Samson

Yves Samson

Kereon

Frank Behnisch

Frank Behnisch

CSL Behring

Note: All times mentioned are CEST.

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” correspond 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 Event is aimed at managers from the pharmaceutical industry, suppliers and service companies who plan, qualify and operate IT infrastructure in a GxP Environment.

Programme

IT / OT Infrastructure Qualification and Operation in a GMP Environment

Seminar Programme as PDF

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
Workshop: “How can you ensure IT and QA work together?”
Although there needs to be quality oversight of IT operations and associated records, what is the best way for IT and Quality to collaborate? Suggestions made in the workshop will be discussed with the course attendees.
 
Content of an Agreement with an IT Service Provider
Annex 11 clause 3 requires that there is a formal agreement between an IT service provider and the business but provides little detail other the document should include clear statements of the responsibilities of the third party. What else is required in an IT agreement?
  • Scope of the IT services provided
  • Roles and responsibilities of both parties
  • Reporting with metrics against defined service Levels
  • Escalation pathway
  • Is an agreement for an internal IT department the same as a cloud service Provider?
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
Change and Configuration Management
  • Regulatory requirements
  • Definitions of change control and configuration management
  • Outline of a change management process
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 suppor
  • PEN testing
Incident and Problem Management
  • Definition of incident and problem
  • Incident investigation
  • Collating incidents into problems and their resolution
  • Linking with change control
Qualification Documentation
  • QP – Qualification Plan
  • TRS – Technical Requirements Specification
  • CS – Configuration Specifications
  • IQ – Installation Qualification a.k.a. Configuration Testing
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
Workshop: Disaster Recovery Planning
Business continuity is an Annex 11 requirement. What should a disaster recover plan cover? How detailed should it be? What would be the triggers to activate a plan? How should it be tested? Does it need to be reviewed? If so how frequently? Could the same plan apply equally to an on-premises and cloud computerised system?
 
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
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
Case Study: Central Backup Management System
  • Requirements
  • Verification
  • Risk assessment
  • Configuration specification
    • Server / Agent / Operating parameters
  • Configuration Testing (IQ)
  • Functional Testing (OQ)
  • Supporting SOPs
  • Operation
Case Study: Firewall Qualification
  • Requirements
  • Risk assessment
  • Configuration specification
  • Configuration Testing (IQ)
  • Functional Testing (OQ)
  • Operation

stop

This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager" Learn more

ECA-Member*: € 2290,-
Non ECA Member*: € 2490,-
EU/GMP Inspectorates*: € 1245,-
APIC Member Discount*: € 2390,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

icon
Further dates on-site
Further dates on-site
Not available
icon
Further dates online
Further dates online
Not available
icon
Recording
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

Woman with headset

Go back

Testimonials about our courses and conferences

"Great material and speakers" and "Great speakers a lot of experience and sharing"

Felipe Gonzalez, Mucos Emulsionsgesellschaft mbH
Live Online Training - Granulation & Tableting, September 2024

"The lectures were very informative, interesting and entertaining."

Albert Godoy Hernández, Company synaffix
Live Online Training - GMP Auditor Practice, October 2024

"Really useful training which I will use in my daily work."

Regina Mommaerts, Galapagos NV
Live Online Training - GMP Auditor Practice, October 2024

"Wonderful format of the sessions: Good range of participations and experience in the team. Would love to attend another one soon."

Roopasi Mathi, Wacker Biotech B.V.
Live Online Training - GMP Auditor Practice, October 2024

"Very good balance between general and detailed information"

Dr Ralf Albrecht, Tillotts Pharma AG
Live Online Training - Granulation & Tableting
September 2024

"Nice presentations: easy understanding, quite visual"

Susana Manrique, Boehringer Ingelheim España, S.A,
Live Online Training - Granulation & Tableting, September 2024

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023