Yves Samson
Kereon
Referent:innen
Dr Robert Stephenson
Rob Stephenson Consultancy
Frank Behnisch
CSL Behring
Zielsetzung
As a specialist for the validation of computerised systems, this Online Training 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
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
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.
Technical Details
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:
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:
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.
Programm
Introduction – Gain Understanding of Delegate Experience and Background
Case Study: What the Delegates expect
Case Study: 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
Case Study: 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?
Case Studies: 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
Requirements: The Good, the Bad and the Ugly
- Good, bad, and could-be-better requirements
- Testability
- Use of templates / boilerplates
- What you should never write
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
Design Review – How to Apply Critical Thinking?
- CSA – Computer Software Assurance
- Scaleable Risk Management
- Document Review
Case Study: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
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
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
Code Review
- Principles of code review
- Regulatory expectations of code review
- Carrying out code reviews
- Recording and documenting code Reviews
Real Life Qualification / Validation Projects
- Real Life Qualification / Validation Projects
- Requirements
- Constraints
- Issues identified
- Lessons learned
Recording from 11-13 May 2022
Duration of Recording: Appr. 15 h
| ECA-Member*: | € 1790,- |
| Regular Fee*: | € 1990,- |
| EU/GMP Inspectorates*: | € 995,- |
| APIC Member Discount*: | € 1890,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Computer Validation Manager"
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E-Mail: info@concept-heidelberg.de
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