Analytical Instrument Qualification and System Validation

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. 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 between the presentations.

Topics: Computer System Validation seminar, USP <1058>, GAMP 5, equipment calibration, system validation, qualification and validation strategy, archive raw data from hybrid systems, Analytical Instrument Qualification, USP General Chapter <1058>, instrument qualification lifecycle, 21 CFR Part 211, Part 11, PIC/S, EU Annex 11, GMP Computer Systems, Laboratory Computerized Systems, Use of Excel in QC Laboratory, revalidation of chromatography, data security and integrity issues.