David Nettleton
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.
We’ll explain how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR). We’ll describe what the regulations mean for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation.
Attending this webinar will get you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.
Learning Objectives
Upon completion of this session, attendees will learn:
Areas Covered
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
8. Validation
9. SaaS/ Cloud Hosting
10. SOPs
11. Annex 11
12. EU GDPR
Who will benefit
This webinar is intended for professionals in the Medical Device, Biotechnology, and Pharmaceutical Industry. Personnel in the following roles will benefit:
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. He is involved with developing, purchasing, installing, operating, and maintaining computerized systems used in FDA-compliant applications. He has completed more than 300 mission-critical laboratory, clinical, and manufacturing software implementation projects. His most recent book is Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates, which provides fill-in-the-blank templates for completing a COTS software validation project.
