Laboratory Systems Validation
One Day Training Course
Validation of equipment and methods is a vital element in 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; ICH, USP, 21 CFR Part 11 and GAMP.
On successful completion of this training course, delegates should be able to:
Who Should Attend
Guidelines for Laboratory System Validation focusing on the current regulations from the FDA and EU authorities in the area of GLP.
Laboratory Equipment Validation - The life cycle for laboratory equipment validation from specification to installation validation and start up for a typical lab equipment project.
Contents of key documents / activities such as URS, FDS, VMP, IQ, OQ and PQ as applied to the laboratory environment.
Laboratory Method Validation- the ICH methodology for analytical procedures. Methods requiring verification and validation of these methods using a standard approach.
Laboratory Software Validation Considerations – control of computerised systems within the laboratory environment. Security, Back-up, Disaster planning, and the implications of 21 CFR part 11.
Course Dates & Venues
9.00am - 5.00pm
Public Course Cost
€395 (includes course documentation, lunch and refreshments)
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.
Delegates will receive a very comprehensive course manual.