Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR 2018 is a webinar that covers topics such as:
- How to write a Data Privacy Statement
- Which data and systems are subject to Part 11 and Annex 11
- Avoid 483 and Warning Letters
- What the regulations mean, not just what they say
- Understand the current industry standard software features for security, data transfer, audit trails, and electronic signatures
- Requirements for local, SaaS, and cloud hosting
- SOPs required for the IT infrastructure
- How to use electronic signatures, ensure data integrity, and protect intellectual property
- Reduce validation resources by using easy to understand fill-in-the-blank validation documents
- Product features to look for when purchasing COTS software
Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR 2018 is intended for:
- QA/QC
- GMP,GCP,GLP,Regulatory Professionals
- Auditors
- IT
- Software Vendors, Hosting Providers
- Managers and Directors