ANALYTICAL INSTRUMENT QUALIFICATION AND COMPUTER SYSTEM VALIDATION – JUNE

Analytical equipment should be qualified and computer systems should be
validated to demonstrate suitability for their intended use. In order 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. Recent EU and FDA reports demonstrate that
qualification, validation and electronic records are priority areas for
inspection.

The large number of FDA warning letters and the frequency of EU
enforcement action in these areas demonstrate that companies
sometimes struggle to understand or implement the regulations.
This 2-day course guides attendees through equipment qualification,
calibration and computer system validation processes from planning
to reporting. It also explains regulatory requirements in these areas,
including EU and US GMPs, as well as data integrity guidance
documents from national and international regulatory bodies.

The course not only ensures a full understanding of the regulations and
guidelines for equipment and records but helps attendees to develop a
risk=based approach to compliance. Interactive exercises will be dispersed
into and in-between presentations.