Yves Samson
Kereon
Referent:innen
Dr Robert Stephenson
Rob Stephenson Consultancy
Frank Behnisch
CSL Behring
Zielsetzung
Computerised System Validation: Introduction to Risk Management
- Get to know the current risk management approaches of ICH Q9 and GAMP®5 2nd Edition
- Become familiar with the use of the latest methods and tools for risk analysis when validating computerised systems
- Learn how the activities involved in the validation of computerised systems can be controlled efficiently by means of risk management
- In 3 workshops you can see how these procedures are applicable
Computerised System Validation: The GAMP® 5 Approach
Why you should attend this Training:
- You will systematically be introduced to the principles and methods of the validation of computerised systems (according to GAMP®)
- You will learn the skills to plan, implement and document effectively validation activities for computerised systems and to assess them with respect to their GxP compliance
- In workshops / interactive sessions you can see how the theoretical foundations will apply practicable
Hintergrund
Computerised System Validation: Introduction to Risk Management
Current GMP regulations and guidelines (EU-GMP Guide Annex 11 ‘Computerised Systems’, ICH Q9, GAMP®5, ASTM E2500-20) focus more and more on the topic of risk management. However, the regulations do not offer much concrete advice on how their principles should be translated into practice during the validation and operation of computerised systems. Therefore, it is the aim of this course to provide you with practice-oriented guidance in performing this task.
Computerised System Validation: The GAMP® 5 Approach
Computerised systems are a central factor determining work sequences in the pharmaceutical industry. Their use increases product safety and saves time and costs of manual intervention. This creates the requirement and necessity, however, to validate all computerised systems which can influence the quality of pharmaceutical products.
The basis of the training will be the current requirements for the validation of computerised systems like GAMP® and their GxPoriented application in practice.
Experts from the pharmaceutical industry and from the GAMP® Committee will show you efficient ways to validate your computerised systems.
The basis of the training will be the current requirements for the validation of computerised systems like GAMP® and their GxPoriented application in practice.
Experts from the pharmaceutical industry and from the GAMP® Committee will show you efficient ways to validate your computerised systems.
Zielgruppe
Computerised System Validation: Introduction to Risk Management
This Training is directed at employees from Production, Quality Control / Quality Assurance, Engineering, IT who have to deal with risk assessment and risk management in the field of computer validation.
Computerised System Validation: The GAMP® 5 Approach
This Training is directed towards specialists and executives in the pharmaceutical industry entrusted with the planning, implementation and evaluation of the validation of computerised systems.
Programm
Gesamtes Programm als PDF herunterladen
Computerised System Validation: Introduction to Risk Management
Introduction – What Do You Want From This Day?
- Capturing delegates expectations
- Sharing and reducing to key points in groups
- Sharing with all delegates and tutors
An Introduction to Risk Management (including ICH Q9)
- Definition of “Quality Risk Management”
- Principles of Quality Risk Management
- Application of the principles in validation
- Methods of assessing and controlling risk
- Regulatory expectations for risk management
Risk Management the GAMP® 5 Way
- The importance of Risk-based Decision Making
- How the GAMP® 5 Risk Management Approach aligns with ICH Q9
- The 5-Steps you will need to follow described in detail
- Risk Management throughout the System Lifecycle
- Short workshop on Risk Identification and Risk Analysis
Risk Assessment the GAMP® 5 Way
- The simple GAMP® 5 Risk Assessment Method
- Assessment Scales for computerised systems that work
- Functional Risk Assessments and Risk Reduction Strategies
- Using risk to determine Test Rigour
Workshop: Risk Management Applied to a Computerised System
- High Level and System Risk Assessment
- Evaluating identified risks
- Controls to mitigate unacceptable risks
Workshop: Functional Risk Assessment Applied to a Control System
- How to document a FRA
- Classification of risks into H, M, L
- What are the conclusions from the risk assessment?
- What options do you have to mitigate (reduce) the higher risks?
- Using the output to determine verification Tasks?
An Introduction to Risk Ranking
- What is risk ranking?
- How is it carried out?
- How is it documented?
- A few useful applications
Workshop: Applying Risk Ranking to Determine System Remediation Priorities
- How is severity determined?
- How can scales be created?
- Ranking the risks
- Developing a risk-based action plan
Computerised System Validation: The GAMP® 5 Approach
Introduction – What the Participants expect
An open session capturing the expectations of the delegates
An open session capturing the expectations of the delegates
Validation Overview
- What do we mean by Validation?
- Validation and Qualification
- Organising and Planning
- Good Documentation Practice
- Specification & Verification
- System Inventory
- System Description
Computerised Systems in Practice
- Definition of a Computerised System
- Scope of CSV (Computerised System Validation)
- Laboratory Equipment
- Automation / Process Control
- Facility Management
- GxP Applications – GCP / GLP / GMP / GDP / GVP
- IT / OT Infrastructure
Regulatory Framework Overview
- GxP: Regulated Good Practices
- EudraLex
- Relevant Regulatory Framework for CSV Purposes
- US GxP Regulations
- Industry Standards
Annex 11 “Computerised Systems” to European GMP
- General principles
- Project phase
- Operation
- ERES requirements
- Annex 11 vs 21 CFR Part 11
- How can you implement it?
Workshop: Self Evaluation of Compliance with Regulatory Expectations
The GAMP® 5 2nd Edition: A Risk-Based Approach to Compliant GxP Computerised Systems
- Applicability
- GAMP® 5 Key Principles
- Life Cycle / ASTM E2500-13 / V-Model
- Guide Structure
- Risk Management according to ICH Q9
Data Integrity Considerations for CSV
- What data are relevant?
- ALCOA+: Data Integrity criteria
- Paper vs hybrid vs electronic systems
- Data integrity requirements for CSV projects
Specifying Requirements
- Importance of Requirements Specification (RS)
- RS Scope and Contents
- Roles & Responsibilities
- Requirements Good Practices
- POLDAT
GAMP® 5 Software Categories
- System Structure
- Software Categories 1, 3, 4, 5
- End User Application
- User View vs IT Perspective
Workshop: Software Categorisation According to GAMP® 5
Functional Specifications – Building the Bridge
- Importance of URS – FS linking
- FS Scope and Contents
- Roles & Responsibilities
- FS and FRA
- FS Good Practices
Workshop: Specifying Requirements - URS vs. FS
Design Specification
- CS – Configuration Specification
- Detailed Specification
- SDS – Software Design Specification
- SMS – Software Module Specification
- HDS – Hardware Design Specification
- NDS – Network Design Specification
Requirement Traceability
- Regulatory expectation vs Good Engineering Practice
- Vertical Traceability / Horizontal Traceability
- How to trace? - Embedded Traceability / Traceability Matrix
Design Review … More Than a Milestone: A Process
- GAMP®5 recommendation on ‘Design Review’
- Functional & technical design review
- Scaleability of the review activities
- Design review: a life cycle supporting process
- Design review documentation
- From ‘Design Review’ to ‘Periodic Evaluation’
Validation Planning
- CSV: A Life cycle approach embedded into the QMS
- Validation Master Plan
- Qualification & Validation on Project / System Level
- Qualification / Validation Plan
- Supplier Assessment / Supplier Management
- Risk Management
- Documentation
- Verification
- Supporting Processes / System Release
Workshop: Validation Planning
Testing of GxP Systems
- Verification vs Validation Terminology
- Software testing
- Acceptance testing / Factory acceptance test (FAT) / Site acceptance test (SAT)
- Qualification testing
- Installation qualification (IQ) / configuration testing
- Operational qualification (OQ) / functional testing
- Performance qualification (PQ) / requirements testing
- Good Testing Practice
- Management of test environment
- Verification of data migration activities
- Optimising the test strategy
Test Incident Management
- Test incident management overview
- What is a test incident?
- Test incident Management process
- Taking a risk-based approach
Workshop: Test Incidents
Change and Configuration Management During the Project Phase
- Regulatory requirements
- Configuration management
- Change management
- Responsibilities
- Recommendation
- When to start?
- Areas of concern
Workshop: Change Management
CSV – Specific Aspects: Automation
- System Overview / Specifications
- GAMP®5 and risk analysis
- Findings & consequences
Validation Reporting and Handover to Operation
- Linking the Validation Plan and Report
- Key documents
- Validation summary reports
- Handover to Operation
CSV: Presentation to Inspectors
- Managing the inspection
- What inspectors want to see
- Warning Letters and 483s
- Inspection experiences
- Lessons to learn
| ECA-Member*: | € 2690,- |
| Non ECA Member*: | € 2890,- |
| EU/GMP Inspectorates*: | € 1445,- |
| APIC Member Discount*: | € 2790,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Aufzeichnung 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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