Course No 16071
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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.
The GAMP 5 Approach
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
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 Requirement 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?
GAMP®5 five steps approach
Practical approach to Risk Management: High Level Risk Assessment – HLRA, System Risk Assessment – SRA, Functional Risk Assessment - FRA
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 scaleability
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
Sources of changes
System Overview / Specifications
GAMP® and risk analysis
Findings & consequences
Validation Reporting & Presentation to Inspectors
The link between the plan and the report
Validation summary reports
Style and emphasis
Managing the inspection
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 summery report
Self Evaluation of Compliance with Annex 11
Workshop 2: Evaluation of a User Requirement 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 requirements specification.
What is a URS?
Why is it important?
Contents of a URS
Characteristics of good 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
Workshop 6: Change Control
The participants will work on a number of case studies
and define the change control activities needed.
Change Control forms