Learn valuable insights and strategies from industry experts.
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
1. What 21 CFR Part 11 means today
• Purpose of Part 11
2. What does Part 11 mean?
• SOPs
• System features
• Infrastructure qualification
• Validation
3. Security standards
• Roles
• Usernames and passwords
• Restrictions and logs
4. Data transfer standards
• Deleting data
• Encryption
5. Audit trail standards
• Types of data
• High risk systems
6. Electronic approval standards
• Electronic signatures
• Single sign-on
• Replacing paper with electronic forms
7. Infrastructure qualification
• How to efficiently document qualifications
8. Validation
• Software validation for vendors
• Computer system validation for users
• Fill-in-the-blank templates
• Change control re-validation
9. SaaS/Cloud hosting
• Responsibilities for software vendor and hosting provider
• Evaluation criteria
• Hosting requirements
10. SOPs
• IT, QA, validation
• Software development
11. Annex 11
• Comparison with Part 11
12. EU GDPR
• Data Privacy Statement
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..
Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU GDPR software validation, and computer system validation. He is involved with the development, purchase, installation, operation, and maintenance of 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.
