Faculty: David Nettleton | Code: FDB3452
This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and 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.
WHO SHOULD ATTEND:
AREAS COVERED IN THE SESSION:
1. What 21 CFR Part 11 means today
2 What does Part 11 mean?
3. Security standards
4. Data transfer standards
5. Audit trail standards
6. Electronic approval standards
7. Infrastructure qualification
9. SaaS/Cloud hosting
11. Annex 11
12. EU GDPR
David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is “Risk Based Software Validation – Ten easy Steps” that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects.