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
Die Veranstaltung hat bereits stattgefunden. Suchen Sie nach Wiederholungsterminen und weiteren, themenbezogenen Seminaren auf der Seite GMP Seminare/-Konferenzen nach Thema.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