Laboratory Systems Validation Training Course

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Our fully interactive Laboratory Software Validation course provides attendees with the knowledge and skills they need to comply with European, US and Worldwide software validation requirements. The course is fully tutor-led and focuses on the practical implementation of software validation requirements, providing attendees with a well-thought-out approach and real-world implementation methodologies to help achieve compliance and assure consistency of performance of computerised systems. This course covers the validation of standalone software such as LIMS systems, statistical packages and databases as well software contained in laboratory equipment ranging in complexity from centrifuges to integrated HLPC systems.

The course also covers the latest FDA Requirements and Guidance on Electronic Records and Signatures (21 CFR Part 11) and Quality Risk Management as applied to Software Validation and Computer Systems Validation. The course involves practical group exercises which take the learner through the entire validation cycle with comprehensive feedback from the course tutor throughout.

For abbreviations used in this brochure, see end of brochure.

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Day 1

The Need for Software Validation in the Laboratory
European and FDA Regulations and Guidance on Laboratory Software Validation
The latest FDA Guidance on Software Validation New
Group Discussion the latest FDA Guidance on Software Validation New
The GAMP Approach to Software Validation
The V Model ApproachV Model Approach interactive exercise
Software Validation Planning - designing Master Validation Plans
Requirements Specifications - Case Study writing a URS
Application of Risk Analysis to Software Updated Content
Software Design Qualification
Requirements Tracing – using the RTM to plan qualification testing

Day 2

Case Study writing an equipment IQ Protocol
Software Testing and Software Test Environments
Software Testing Interactive Exercise
Case Study writing an equipment OQ Protocol
Statistical Rationale for Samples Sizes Updated Content
Electronic Records and Electronic Signatures
21 CFR Part 11 Interactive Exercise
Application of the FDA Guidance on Part 11
Data Integrity and Software Validation New
Software Performance Qualification
Case Study - writing a Software PQ Protocol Updated Content
Leveraging Supplier documentation for off-the-shelf systems Updated Content
Validation Reporting - How to Report on Software Validation testing New
Maintaining the Validated State Updated Content
End of Course Assessment. New

Laboratory Managers, Supervisors and Technicians who wish to increase their understanding of Laboratory Systems and Software Validation
Laboratory Staff who will be involved in the validation of laboratory systems, equipment and software.
IT personnel who will be involved in laboratory software valid

Upon completion of this course, participants will be able to;

Identify the regulatory requirements for Laboratory Software Validation
Categorise software in accordance with GAMP guidelines
Apply the V Model to Laboratory Software Validation
Appreciate European and FDA Guidance publications on Software Validation
Design a software Validation Master Plan
Write User Requirements for software and computerised systems
Assess software and computerised systems risks
Identify the main requirements for Electronic Records and Electronic Signatures
Apply the FDA Guidance on 21 CFR Part 11 to software systems
State the main Data Integrity requirements,
Complete a software DQ
Write IQ test cases for computerised systems
Identify challenge tests for software systems
Write Software OQ test cases
Write Software PQ test cases
Leverage vendor documentation to minimise validation effort
Report on Software testing results
Assist in ensuring that the validated state is maintained

John Lafferty

John Lafferty is a Quality professional with over 25 years expe...

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In-House Courses
Course tutor will contact your organisation in advance. In-house courses can be customised to meet your organisation’s specific requirements. Where appropriate, course exercises can be carried out using procedures, data etc from your organisation.

Course Manual
Delegates will receive a very comprehensive course manual.

Acronyms used in this document.

CFR	Code of Federal Regulation (US Federal Law)
EU	European Union
FDA	Food and Drugs Administration
FDS	Functional Design Specification
GAMP	Good Automated Manufacturing Practice (Industry Guidance)
GLP	Good Laboratory Practice
GMP	Good Manufacturing Practice
IQ	Installation Qualification
LIMS	Laboratory Information Management Systems
OQ	Operational Qualification
PQ	Performance Qualification
URS	User Requirements Specification
MVP	Master Validation Plan

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Snapshot

Course Code

L009

Duration

2 training days

Public Price

Virtual Training: £605

(includes course documentation)

Delivery Mode

This programme is delivered by Classroom, Virtual Training, or In-Company training

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