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Oct
13

Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR

 
 Seminar/trade show (noCPF)

When:

  13 Oct 2021 through 14 Oct 2021

Where:

  Online Event | United States

Website URL:

  https://www.complianceonline.com/computer-system-validation-reduce-costs-and-avoid-483s-seminar-training-80005SEM-prdsm?channel=Brownwalker

Sponsoring organization:

  Compliance Online

Categories:

  Physical Science & Math - Other

Keywords:


Event description:

This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments. It details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation. Understand the specific requirements associated with local and SaaS/cloud hosting solutions. Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Participants learn how to decrease software implementation times and lower costs using a 10-step risk-based approach to computer system validation. The instructor reviews recent FDA inspection tre... Read more

Posting date:

26 August 2021  |  146 views

Placement:

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