Computer Validation: Introduction to Risk Management + GAMP 5 Approach
Save up to EUR 490,- by booking both courses!
Im Auftrag der ECA Academy
Vienna, Austria
Seminar Nr. 17246
Unser Seminarservice
Kosten
| Non ECA Member: | EUR 2390,-- |
| ECA-Member: | EUR 2190,-- |
| EU/GMP Inspectorates: | EUR 1440,-- |
| APIC Member Discount: | EUR 2290,-- |
Alle Preise zzgl. MwSt.
Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de
Sprecher
Frank Behnisch, CSL Behring GmbH
Yves Samson, Kereon
Dr Robert Stephenson, Rob Stephenson Consultancy
Yves Samson, Kereon
Dr Robert Stephenson, Rob Stephenson Consultancy
Programm
Computer 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
An Introduction to Risk Ranking
- What is risk ranking
- How is it carried out
- How is it documented?
- A few useful applications
Workshop 1: Risk Assessment in Validation
Risk management applied to a computer system
Risk management applied to a computer system
- Evaluating identified risks
- Classification of risks into H, M, L
- Controls to mitigate unacceptable risks
- Links to the validation plan and protocols
In this workshop, delegates will use the GAMP methodology. The participants will work on a case study in which the risks associated with a computer system are assessed and managed to reduce the testing workload in validation.
Workshop 2: Risk Management in Validation
Risk management applied to a control system
Workshop 2: Risk Management in Validation
Risk management applied to a control system
- What are the conclusions from the risk assessment?
- What options do you have to mitigate (reduce) the higher risks?
- How will the output affect the protocol?
Based on a real case study, delegates will use the same risk assessment techniques to determine where to focus the qualification of a packaging line.
Workshop 3: Applying Risk Ranking to determine periodic review priorities
Workshop 3: Applying Risk Ranking to determine periodic review priorities
- How is severity determined?
- How can scales be created?
- Ranking the risks
- Developing a risk-based action plan.
Delegates will apply the techniques of risk ranking to determine which systems present the highest risk to the patient and should therefore be reviewed first.
Computer Validation: The GAMP 5 Approach
1st Day
Introduction – What the participants expect
An open session capturing the expectations of the delegates
Laws, Regulations and Guidelines for Computer Validation
Computer Validation: The GAMP 5 Approach
1st Day
Introduction – What the participants expect
An open session capturing the expectations of the delegates
Laws, Regulations and Guidelines for Computer Validation
- The historical perspective
- Current regulations and regulatory guidelines from US
- New regulatory guidance (GAMP® 5, GAMP® Good Practice Guides, ASTM)
- New industry guidance
- Regulatory training
- Harmonisation
Electronic Records and Signatures
- What Part 11 means – Now!
- Identify e-records in predicate rules
- Identify risks to records
- Identify appropriate controls for records
The GAMP® 5 Approach to Computer Validation
- Validation needs structure
- The GAMP® approach
- What is new in GAMP® 5
- General validation activities
- The GAMP® Categorisation System
- Life Cycle cost reduction
The EU Annex 11 “Computerised Systems”
- What are the important points?
- How can you implement it?
User Requirements Specifications (URS)
- Why do we need user requirements and specifications?
- What should a URS look like – and who should be involved?
- How to capture requirements effectively
- How does User Requirements documentation go wrong?
Risk Management
- Q9 process
- GAMP®5 five steps approach
- Practical approach to Risk Management
- High Level Risk Assessment – HLRA
- System Risk Assessment – SRA
- Functional Risk Assessment - FRA
2nd Day
Validation Planning
Validation Planning
- Why is a validation plan important?
- Definitions and regulatory expectations
- Building risk management into planning phase
- Structure and contents of validation plans
- Discussion of best approach
- The impact of scalability
Specifications, Design Review and Traceability
- What sorts of specifications are needed?
- How are they constructed?
- Can they be combined?
- How to carry out a design review?
- How to construct a traceability matrix?
Protocols, Test Scripts and Deviation Management
- Principles of Risk-Based Qualification
- Leveraging the Supplier
- Commissioning vs Qualification
- Test Script Design
- Deviation Management
Change Control
- Regulatory requirements
- Configuration management
- Responsibilities
- Planned/unplanned changes
- Classification
- Sources of changes
3rd Day
Automation Aspects
Automation Aspects
- System Overview / Specifications
- GAMP® and risk analysis
- Findings & consequences
Validation Reporting & Presentation to Inspectors
- The link between the plan and the report
- Key documents
- Validation summary reports
- Style and emphasis
- Managing the inspection
Regulatory Comments
- Recent general trends
- Highlights from Warning Letters and 483s
- Lessons we must learn
Introduction to IT Infrastructure Qualification
- The qualification lifecycle
- How to deal with user requirements
- Qualification documentation
- Critical issues
- Qualification summary report
Workshop 1: Self Evaluation of Compliance with regulatory expectations
Workshop 2: Evaluation of a User Requirements Specification
A short review of the URS and how to write specifications, as a prelude to a workshop in which delegates will evaluate a real requirement specification
Workshop 2: Evaluation of a User Requirements Specification
A short review of the URS and how to write specifications, as a prelude to a workshop in which delegates will evaluate a real requirement specification
- What is a URS?
- Why is it important?
- Contents of a URS
- Characteristics of good specifications
- Testable specifications
Workshop 3: Validation Planning
- Based on considerations of the type of application, knowledge of the supplier and how it will be used, delegates will work out the best approach to delivering the benefits of a GxP system
- What are the risks associated with delivering the system?
- What options do you have to manage the most critical risks?
- How can they best be managed?
- What are the key issues to monitor to ensure delivery of the project benefits?
Workshop 4: Risk Management in Protocol Planning
Based on a real case study, delegates will use the same risk assessment techniques as in Workshop 2 to determine where to focus the qualification of a packaging line.
Based on a real case study, delegates will use the same risk assessment techniques as in Workshop 2 to determine where to focus the qualification of a packaging line.
- Risk management applied to a control system
- Using FMEA to assess risks to be managed and controlled in validation
- Identifying options to mitigate (reduce) the higher risks
- Using the output in creating the testing protocol
Workshop 5: Managing Deviations
In this workshop examples of deviations will be examined and methods of resolution discussed. The examples are based on real-life protocols.
In this workshop examples of deviations will be examined and methods of resolution discussed. The examples are based on real-life protocols.
- Test failures found during IQ/OQ
- Manage the deviations
- Suggest solutions
- Using the output in creating the testing protocol
Workshop 6: Change Control
The participants will work on a number of case studies and define the change control activities needed.
The participants will work on a number of case studies and define the change control activities needed.
- Change Control forms
- Approval process
- Standard Changes
- Committees
GMP Seminare nach Thema
- Qualitätssicherung / Dokumentation
- Regulatory Affairs and Compliance
- Entwicklung / Prüfpräparate
- Datenintegrität
- Qualitätskontrolle / Analytik / Statistik
- GDP - Lager - Logistik
- Computervalidierung
- Validierung / Qualifizierung
- GMP in Produktion / Technik
- GMP für Wirkststoffe und Hilfsstoffe
- Medizinprodukte und Kosmetika
- GMP Basisausbildung
- Packmittel / Verpackung
- Hygiene / Mikrobiologie / Steril / Biotechnologie
- Einkauf / Betriebswirtschaft / Effizienz
- Sonstige Themen
- European Conferences and Education Courses