Analytical equipment should be qualified, and computer systems should be validated to demonstrate suitability for their intended use. To be acceptable to regulatory authorities, electronic records must comply with 21 CFR Part 11, Annex 11 to EU GMPs and more recent data integrity guidance
This 2-day course guides attendees through equipment qualification, calibration and computer system validation processes from planning to reporting.
- Learn about the regulatory background and requirements for equipment qualification according to USP <1058> and computer system validation according to GAMP 5
- Be able to explain the difference between equipment calibration, qualification and system validation
- Learn which equipment/systems need to be qualified or validated
Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016,