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Computerised System Validation

11-14 June 2024, Vienna, Austria

Seminar-Nr. 21042

Referent:innen

Frank Behnisch

Frank Behnisch

CSL Behring

Yves Samson

Yves Samson

Kereon

Dr Robert Stephenson

Dr Robert Stephenson

Rob Stephenson Consultancy

Stefan Münch

Stefan Münch

Körber Pharma Consulting

Zielsetzung

Leveraging Suppliers:
  • Learn what activities and deliverables you should expect to see from your IS/IT supplier to demonstrate Supplier Good Practice
  • Learn how to verify your supplier’s capabilities so that there are “no surprises”.
  • Learn how to plan validation (verification) activities, leveraging the expertise of your supplier
  • Learn how to minimise duplication of effort between the supplier and your regulated company in order to achieve lean and effective processes throughout the system life cycle
  • Learn how to work with your supplier in order to build a strong and lasting client-supplier relationship
 
Computerised Systems Validation Master Class:
 
As a specialist for the validation of computerised systems, the event will provide you with
  • Suggestions on how current regulatory guidance on computerised systems relating to data integrity, critical thinking and CSA (Computer Software Assurance) can be put into practice
  • Real-life examples of how validation effort can be scaled according to risk-based approaches
  • Answers to specific questions, e.g. on source code review or on creating specification documents
  • The opportunity to bring questions from your own practice up for discussion

Hintergrund

Leveraging Suppliers:
Recognising the potential savings and flexibility available, regulated companies are increasingly withdrawing from ‘in-house’ developed solutions and looking to their external suppliers to provide them with innovative and compliant products and services which fulfil their operational and business needs.

The EU-GMP Annex 11 on Computerised Systems states that ‘the competence and reliability of a supplier are key factors when selecting a product or service provider’; ‘Leveraging Supplier Involvement’ is also one of the 5 key concepts of the GAMP®5 guidance ‘A Risk-Based Approach to Compliant GxP Computerized Systems’.

This course aims to provide attendees with the knowledge, and opportunities to practice the skills required, to achieve successful partnerships with their IS/IT suppliers and to improve
 
 
Computerised System Validation Master Class:
The V-model has become a standard worldwide methodology for the validation of computerised systems. Regulatory requirements, as well as industry guidelines, like GAMP®5, are orientated towards this model. In practice, you as a validation specialist will want to know how to apply this model to current and increasingly complex validation projects.

Zielgruppe

Leveraging Suppliers:

This ECA Training Course is directed at employees from Production, Quality Control/Quality Assurance, Engineering and IS/ IT, who have to assess, manage or work with computerised system or service providers.
 
The training course will also be of value to representatives from supplier organisations that are working or seeking to work with Regulated Companies in the Life Sciences Sector.
 
 
Computerised System Validation Master Class:
 
The Master Class is directed at employees from
  • IT
  • Production
  • Engineering
  • Quality Assurance
  • Quality Control
Participants should already have gained experience in the validation of computerised systems, and preferably will have also attended a basic CSV Course.

Programm

Computerised System Validation

Gesamtes Programm als PDF herunterladen

Programme Leveraging Suppliers - 11 June 2024
 
Introduction – What the Participants Expect
An open session capturing the expectations of the delegates.
 
Leveraging Suppliers Expertise: An Overview of Good Practice
  • What is current Good Practice?
  • Optimising Supplier involvement
  • Integrating the supplier’s  expertise and deliverables into your validation process
  • How to do more with less
Performing a Supplier Assessment
  • Why Assess the Supplier?
  • The Overall Process
  • Assessment Topics
  • Types of Assessment
  • Corrective Actions & Follow Up Audits
Workshop: Selecting a Supplier
  • What factors to take into account?
  • How to focus the assessment?
  • How to engage with the supplier?
  • How to report and manage the findings?
  • Regulatory expectation
Supplier Audit – The Supplier’s View
  • Define the role of the supplier
  • What must the supplier do?
  • What must the regulated company do?
Quality Planning within a Supplier’s QMS - Developing a Quality Plan that Delivers
  • Quality Management System
  • Establishing Requirements
  • Producing Specifications
  • Testing and Release
  • Support and Maintenance
Workshop: Quality Planning within a Supplier’s QMS - Developing a Quality Plan that Delivers
 
 Leveraging Supplier Testing
  • Test script development
  • Test script execution
  • Test script review and approval
 
Programme Computerised System Validation Master Class - 12-14 June 2024
 
Introduction – Gain Understanding of Delegate Experience and Background

Workshop 1: What the Delegates expect
  • Capturing delegates expectations
  • Sharing and reducing to key points in groups
  • Sharing with all delegates and tutors
Current Challenges and Evolution for CSV Activities
  • What does compliance really mean?
  • Data Integrity
  • Securing operation: cybersecurity
  • Project agility
  • Cost efficiency vs effective risk management
  • Applying critical thinking
Roles, Responsibilities and Governance
  • PQS – Pharmaceutical Quality System according to ICH Q10
  • Responsibilities
    • Operational ownerships
    • Supporting roles
  • QA oversight
Workshop 2: Governance Benchmark
  • Polling Exercise plus facilitated discussion
  • IT and System Governance
  • CSV Roles and Responsibilities
  • Role of Quality Unit
Practical Use of Scalability
  • What do we mean by Scalability?
  • How does it work in practice?
  • How can we combine documents successfully?
  • How much is enough?
Workshop 3: Scaleability of Validation Activities
  • LIMS – Laboratory Information Management System
  • Laboratory computerised equipment
  • Process control system: PLC – Programmable Logic Controller
Writing Requirements Documents
  • Requirements gathering
  • Writing good requirements
  • Use of templates / boilerplates
  • Requirement Quality
Ideal Content of a CSV SOP
  • Embedding the CSV SOP into the PQS
  • Topics to address
Data Integrity and Record Management: A Necessary Long-Term Approach
  • Regulatory context
  • Document life cycle
  • Retention requirements and constraints
  • Supporting processes
  • Areas of concern
System Classification – A Record-based Approach
  • Needs for record-based system classification
  • Classification criteria
  • Class A, B, C, D
Workshop 4: System Classification
 
Design Review – How to Apply Critical Thinking?
  • CSA – Computer Software Assurance
  • Scaleable Risk Management
  • Document Review
Workshop 5: Design Review Scaleability
  • Combining Risk Management & Design Review
Bringing Legacy Systems into Compliance
  • How to approach legacy system remediation
  • Examples
    • Learning management system
    • Laboratory Instruments
Interactive Session: Good Validation Practices
Open session in which delegates score their CSV approach against 12 good validation practices
  • Each good practice introduced
  • Delegates score themselves
  • Results consolidated and fed back
  • Allows delegates to compare their CSV system against best practice and other practitioners
Alternative & Agile Approaches
  • Alternative software development models
    • Unified Process, Scrum
  • Agility objectives
    • Need for flexible engineering methodologies
  • What Agile engineering is not
    • What Agile engineering needs
  • Practical approaches and recommendation
    • Conditions for success
Validating Spreadsheets
  • Why are spreadsheets high risks?
  • Design considerations
  • What is important (risk again)!
  • How to document spreadsheet validation
Code Review
  • Principles of code review
  • Regulatory expectations
  • Performing code reviews
  • How to document code reviews
Elaboration of a Data Integrity Programme
  • Data Integrity Programme: What to do?
    • Topics to address
    • Action planning
  • Embedding the Data Integrity Programme into the PQS
  • Progress Reporting
Case Studies: Complex Projects
  • Global projects
    • Roles & Responsibilities
    • Data-related requirements
  • Large systems
    • Phase-based implementation and deployment
  • Interface projects
    • Roles & Responsibilities
    • Testing
Today / Future IT Compliance Challenges
  • Open Source Software validation
  • Challenge demands Infrastructure platforms for applications
  • Global systems validation vs local defence
  • Paperless recipes based production – ISA 95 / S 88
  • Cloud Computing – Data Integrity
  • Validating Artificial Intelligence (AI)
  • Challenges for data integrity on Lab-Systems
 
 
Programme Computerised System Validation Master Class - 12-14  June 2024
 
Introduction – Gain Understanding of Delegate Experience and Background

Workshop 1: What the Delegates expect
  • Capturing delegates expectations
  • Sharing and reducing to key points in groups
  • Sharing with all delegates and tutors
Current Challenges and Evolution for CSV Activities
  • What does compliance really mean?
  • Data Integrity
  • Securing operation: cybersecurity
  • Project agility
  • Cost efficiency vs effective risk management
  • Applying critical thinking
Roles, Responsibilities and Governance
  • PQS – Pharmaceutical Quality System according to ICH Q10
  • Responsibilities
    • Operational ownerships
    • Supporting roles
  • QA oversight
Workshop 2: Governance Benchmark
  • Polling Exercise plus facilitated discussion
  • IT and System Governance
  • CSV Roles and Responsibilities
  • Role of Quality Unit
Practical Use of Scalability
  • What do we mean by Scalability?
  • How does it work in practice?
  • How can we combine documents successfully?
  • How much is enough?
Workshop 3: Scaleability of Validation Activities
  • LIMS – Laboratory Information Management System
  • Laboratory computerised equipment
  • Process control system: PLC – Programmable Logic Controller
Writing Requirements Documents
  • Requirements gathering
  • Writing good requirements
  • Use of templates / boilerplates
  • Requirement Quality
Ideal Content of a CSV SOP
  • Embedding the CSV SOP into the PQS
  • Topics to address
Data Integrity and Record Management: A Necessary Long-Term Approach
  • Regulatory context
  • Document life cycle
  • Retention requirements and constraints
  • Supporting processes
  • Areas of concern
System Classification – A Record-based Approach
  • Needs for record-based system classification
  • Classification criteria
  • Class A, B, C, D
Workshop 4: System Classification
 
Design Review – How to Apply Critical Thinking?
  • CSA – Computer Software Assurance
  • Scaleable Risk Management
  • Document Review
Workshop 5: Design Review Scaleability
  • Combining Risk Management & Design Review
Bringing Legacy Systems into Compliance
  • How to approach legacy system remediation
  • Examples
    • Learning management system
    • Laboratory Instruments
Interactive Session: Good Validation Practices
Open session in which delegates score their CSV approach against 12 good validation practices
  • Each good practice introduced
  • Delegates score themselves
  • Results consolidated and fed back
  • Allows delegates to compare their CSV system against best practice and other practitioners
Alternative & Agile Approaches
  • Alternative software development models
    • Unified Process, Scrum
  • Agility objectives
    • Need for flexible engineering methodologies
  • What Agile engineering is not
    • What Agile engineering needs
  • Practical approaches and recommendation
    • Conditions for success
Validating Spreadsheets
  • Why are spreadsheets high risks?
  • Design considerations
  • What is important (risk again)!
  • How to document spreadsheet validation
Code Review
  • Principles of code review
  • Regulatory expectations
  • Performing code reviews
  • How to document code reviews
Elaboration of a Data Integrity Programme
  • Data Integrity Programme: What to do?
    • Topics to address
    • Action planning
  • Embedding the Data Integrity Programme into the PQS
  • Progress Reporting
Case Studies: Complex Projects
  • Global projects
    • Roles & Responsibilities
    • Data-related requirements
  • Large systems
    • Phase-based implementation and deployment
  • Interface projects
    • Roles & Responsibilities
    • Testing
Today / Future IT Compliance Challenges
  • Open Source Software validation
  • Challenge demands Infrastructure platforms for applications
  • Global systems validation vs local defence
  • Paperless recipes based production – ISA 95 / S 88
  • Cloud Computing – Data Integrity
  • Validating Artificial Intelligence (AI)
  • Challenges for data integrity on Lab-Systems
Real Life Qualification / Validation Projects
  • Real Life Qualification / Validation Projects
  • Requirements
  • Constraints
  • Issues identified
  • Lessons learned

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