Overview:
It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR).
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
Validation
Who Will Benefit:
GMP, GCP, GLP, Regulatory Professionals
QA/QC
IT
Auditors
Managers and Directors
Software Vendors, Hosting Providers