Course No 9068
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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 open session capturing the expectations of the delegates. Working in groups delegates derive their requirements from the training event and share them with the 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
An introduction to the principles and terminology used in ICH Q9, Quality Risk Management. The principles will then be applied to the validation life cycle. The regulatory expectations for risk management will be discussed.
Risk Management the GAMP® 5 Way
The GAMP methodology for risk management
Where to apply risk management in validation
Methods of assessing risk
The GAMP® 5 approach to science-based quality risk management is described for delegates to see how important effective risk management is to successful CSV. Scalability of risk identification and risk controls based on system complexity and business process analysis is also discussed.
An Introduction to Risk Ranking
What is risk ranking
How is it carried out
How is it documented?
A few useful applications
This presentation presents the principles of risk ranking and shows how it may be used in a number of applications relating to the compliance of computer systems.
Assessing and Selecting a Supplier
What are the criteria to use to select a supplier?
Why does supplier selection matter?
How should the selection process be conducted?
Delegates will understand the value of identifying a good supplier, the importance of having a good supplier selection procedure and what to look for when selecting the most appropriate supplier for your project.
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
Computer Validation - 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
A review of the laws, regulations and guidelines from both the regulators and industry, right up to the present day, and anticipating new developments.
Electronic Records and Signatures
What Part 11 means – Now!
Identify e-records in predicate rules
Identify risks to records
Identify appropriate controls for records
This session will show how to identify electronic records and review the most common issues arising from the recent FDA regulation. It will show how the risks to the record, will determine the controls to be applied, based on the GAMP® Guidance, published in 2005.
The EU Annex 11 “Computerised Systems”
What is new?
What are the important points?
How can you implement it?
The new versions of EU GMP Guide Chapter 4 Documentation and Annex 11 were published in 2011. You will get an overview about the important points.
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
An overview of all the processes in the computer validation life-cycle, including how the approach to validation can be modified to fit in with the GxP criticality of the application.
Risk Management – A Key Point Review
How to use the FMEA tool to reach better risk-based
How to make use of risk information
A review of the risk management process emphasising key points for its successful application. Special emphasis is paid to documenting risk in such a way that it is useful in change management and in other projects
Programme 2nd Day
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
This session will focus on what is important in a Validation Plan. This will include the information required and the regulatory expectations.
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?
This session will show the interconnectivity between specifications and the importance of getting them right before h/w and s/w are built. It will also introduce the concept of traceability and how it helps the project to stay focussed.
Protocols, Test Scripts and Deviation Management
Principles of Risk-Based Qualification
Leveraging the Supplier
Commissioning vs Qualification
Test Script Design
GAMP® 5 principles are applied to the development of effective testing protocols based on risk, how to get best value from the Supplier’s documentation, good practice guidance when executing test protocols and how to document deviations to ensure compliance.
Sources of changes
The session will attempt to provide practical guidance on the set-up of a change control procedure covering computerised systems.
Programme 3rd Day
GAMP® and risk analysis
Qualification / Validation
Process Control Systems (PCS) and Process Logical Controllers (PLC) are widely used. This session describes specific aspect of automation systems regarding computerised system validation.
Validation Reporting & Presentation to Inspectors
The link between the plan and the report
Validation summary reports
Style and emphasis
Managing the inspection
The relative importance of different validation documents will be discussed from the point of view of presenting a validation study to an inspector. The presentation and the key communication issues will be discussed.
Introduction to IT-Infrastructure Qualification
The qualification lifecycle
How to deal with user requirements
Qualification summery report
The participants will be informed on the basic concepts, critical items and recent trends on the qualification of the Network, Platforms, Back-end and Front-end. This session will focus on the new requirements published in the GAMP® Good Practice Guide “IT-Infrastructure Compliance and Control”
Recent general trends
Highlights from Warning Letters and 483s
Lessons we must learn
We will give you the necessary overview and update of national and international regulations. Beside others you will hear about the “Hot Buttons” of Computer Validation and frequent misconceptions.