Healthcare Training 2021 - Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR

Overview:
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).
What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.
Areas Covered in the Session:
What 21 CFR Part 11 means today
Purpose of Part 11
What does Part 11 mean?
SOPs
System features
Infrastructure qualification