Frank Behnisch
CSL Behring
Computerised System Validation Master Class
Speakers
Yves Samson
Kereon
Dr Robert Stephenson
Rob Stephenson Consultancy
Objectives
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
Background
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.
Target Group
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.
Programme
Seminar Programme as PDF
Introduction – Gain Understanding of Delegate Experience and Background
Workshop 1: What the Delegates expect
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
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
This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager" Learn more
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* also payable by credit card
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Do you have any questions?
Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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