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.
Collapse9:00am to 4:30pm
(includes course documentation)