Laboratory Systems Validation Training Course

Validation of equipment and methods is a vital element of assuring the integrity of results from laboratories in the pharmaceutical, healthcare and medical device industries. This course covers the life cycle for laboratory equipment validation, from requirements specification to installation, operation and performance testing. It addresses the requirements for the control of electronic records and signatures within a laboratory environment. The course is aimed at fulfilling the requirements of the latest industry requirements such as; EU GMP Vol 4 Annex 11, ISO 13485 and 21 CFR Parts 11, 211 and 820, and the GAMP guidelines. This course covers the validation of standalone software such as LIMS systems, statistical packages and databases as well software contained laboratory equipment ranging in complexity from centrifuges to integrated HLPC systems.

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Guidelines for Laboratory System Validation focusing on the current regulations from the FDA and European authorities in the area of GLP will be outlined.

The life cycle for laboratory equipment and software validation from specification to installation, validation and start up for a typical piece of lab equipment will be outlined. The expected content of key documents such as URS, FDS, MVP, IQ, OQ and PQ as applied in the laboratory environment will be discussed. Course participants will gain hands-on experience of writing key elements of validation documents such as; requirements statements, risk assessments and validation test cases.

The course will also cover the ongoing control of both standalone and embedded software within the laboratory environment including requirements for; Security, Back-up, Data Integrity and Disaster Planning. The requirements for electronic records and electronic signatures and in particular the requirements of 21 CFR Part 11 will be outlined. Throughout the course the tutor will discuss ways in which the validation of equipment software and hardware can best be combined.

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

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 validation.

Participants achieve the following learning outcomes from the programme;

Demonstrate a working knowledge of the fundamentals and principles of validation and how they are applied in a laboratory.
Generate key elements of validation documents such as URS, FDS, MVP, IQ, OQ and PQ.
Apply the requirements of 21 CFR Part 11 in the laboratory environment.
Apply ongoing controls to laboratory equipment and software.
Apply the above to both standalone software packages and on-board software embedded in laboratory equipment.

Carmel McCrea Kelly

Carmel McCrea Kelly, BSc in Quality Management & Technology...

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John Lafferty

John Lafferty, B. Tech. in Manufacturing Technology, Six Sigma ...

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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.

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