Computer Validation: Introduction to Risk Management + GAMP 5 Approach - Save up to EUR 490,- by booking both courses!

Computer Validation: Introduction to Risk Management + GAMP 5 Approach  -  Save up to EUR 490,- by booking both courses!

Vienna, Austria

Course No 17246



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Frank Behnisch, CSL Behring GmbH
Yves Samson, Kereon
Dr Robert Stephenson, Rob Stephenson Consultancy


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
  •  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
  •  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
  •  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
  •  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
  •  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
  •  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
  •  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.
  •  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.
  •  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.
  •  Change Control forms
  •  Approval process
  •  Standard Changes
  •  Committees

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