Computer Validation - The GAMP®5 Approach

(Im Auftrag der European Compliance Academy)

Computer Validation - The GAMP®5 Approach <p>(Im Auftrag der European Compliance Academy)

Barcelona, Spain

Seminar Nr. 9062


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Tel.: 06221 / 84 44 0 E-Mail:


Frank Behnisch, CSL Behring GmbH, Germany
Dr David Selby, Selby Hope International, UK
Dr Robert Stephenson, Rob Stephenson Consultancy, UK


This is why you should attend this course:
You will systematically be introduced to the principles and methods of the validation of computerised systems (according to GAMP®)
You will learn the skills to plan, implement and document effectively validation activities for computerised systems and to assess them with respect to their GxP compliance
You have the opportunity to practically apply the theoretical foundations in 7 workshops


Computerised systems are a central factor determining work sequences in the pharmaceutical industry. Their use increases product safety and saves time and costs of manual intervention. This creates the requirement and necessity, however, to validate all computerised systems which can influence the quality of pharmaceutical products.

The basis of the education course will be the current requirements for the validation of computerised systems like GAMP® and their GxP-oriented application in practice.

Experts from the pharmaceutical industry and from the GAMP® Committee will show you efficient ways to validate your computerised systems.


This course is directed towards specialists and executives in the pharmaceutical industry entrusted with the planning, implementation and evaluation of the validation of computerised systems.


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
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
Risk registers
Documenting risk
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
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 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
Deviation Management
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.

Change Control
Regulatory requirements
Configuration management
Planned/unplanned changes
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
Automation Aspects
System Overview
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
Key documents
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 documentation
Critical issues
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”

Regulatory Comments
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.


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