When: |
12 Jul 2021 through 13 Jul 2021 | |
Where: |
Online Event | United States | |
Website URL: |
https://www.complianceonline.com/analytical-instrument-qualification-computer-system-validation-seminar-training-80617SEM-prdsm?channel=Brownwalker | |
Sponsoring organization: |
Compliance Online | |
Categories: |
Medicine & Health - Pharmaceutical / Medicinal |
Keywords:
Event description:
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 r...
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Posting date:
29 May 2021 | 169 views
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