Course Detail

Validation is the term used within the pharmaceutical, healthcare and medical device industries to indicate that a system has been subject to such scrutiny that the results can be practically guaranteed.

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

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. Note: The above syllabus may change during the training course to provide more detail in aspects, which have been ascertained to be of greater value to the trainee.