Two Day Course: Analytical Instrument Qualification and System Validation (Burlingame CA, United States - February 6-7, 2020) - ResearchAndMarkets.com
Summary
DUBLIN--(BUSINESS WIRE)--The "Analytical Instrument Qualification and System Validation" conference has been added to ResearchAndMarkets.coms offering. 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. 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.