The Laboratory Systems Validation training course, to be delivered in Limerick as one-day public programme provides participants with basic principles of system, quipment, method and software validation in laboratory environment.

The Laboratory Systems Validation Programme is also available for delivery as a customised in-company course at clients facilities nationwide in Ireland, including Dublin, Cork, Limerick & Galway.

Pre-requirements:

This course is intended for Laboratory personnel Development Chemists/ Microbiologists.

Participants Study:

• Fundamentals of Validation in a Laboratory Environment
• Validation Documentation
• Analytical Test Method Validations
• 21 CFR Part 11 in a Laboratory Environment.

Course Contents:

• Guidelines for Laboratory System Validation focusing on the regulations surrounding the current FDA and EU authorities in the area of GLP.
• Laboratory Equipment Validation. The life cycle for laboratory equipment validation from procurement, installation testing and startup for a typical lab equipment project will be described. Details on the contents of key documents / activities such as URS, FDS, VMP, IQ, OQ and PQ as applied to the laboratory environment will be discussed.
• Laboratory method validation- ICH text on methodology for analytical procedures explained in detail in terms of definitions, methods to be verified and detailed discussions on validating such methods using a standard approach.
• Laboratory Software Validation Considerations - control of computerised systems within the laboratory environment will be identified n detail with discussions on topics such as Security, Back-up, Disaster planning, and the implications on 21 CFR part 11.

At Course Completion:

• Understand fundamentals and principals of validation and how they are applied to a laboratory.
• Understand the contents of key documents such as URS, FDS, VMP, IQ, OQ, PQ and SQ.
• Understand the fundamentals of analytical test method validations.
• Understand the implications of 21CFR part 11 to the laboratory environment.