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2020 - SaaS/Cloud Risk-Based Validation With Time-Saving Templates

Date2020-12-16

Deadline2020-12-06

Venue, USA - United States USA - United States

Keywords21 CFR Part 11 Compliance; Annex 11 Compliance; Avoid 483s

Websitehttps://www.complianceonline.com/fda-21-...esearchbib

Topics/Call fo Papers

Which data and systems are subject to Part 11 and Annex 11
How to write a Data Privacy Statement
What the regulations mean, not just what they say
Avoid 483 and Warning Letters
Requirements for local, SaaS, and cloud hosting
Understand the current industry standard software features for security, data transfer, audit trails, and electronic signatures
How to use electronic signatures, ensure data integrity, and protect intellectual property
SOPs required for the IT infrastructure
Product features to look for when purchasing COTS software
Reduce validation resources by using easy to understand fill-in-the-blank validation documents

Last modified: 2020-12-03 20:53:37