21 CFR Part 11, SaaS/Cloud, EU GDPR

Website https://worldcomplianceseminars.com/upcoming_webinar | Edit Freely

Category GMP, GCP, GLP, Regulatory, QA/QC, IT, Audits.

Deadline: March 03, 2020 | Date: March 03, 2020

Venue/Country: U.S.A

Updated: 2020-01-06 15:12:15 (GMT+9)

Call For Papers - CFP

David Nettleton Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU General Data Protection Regulation (GDPR), software validation, and computer system validation.

Session Highlights:

• 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

This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR)