Source: https://world-compliance-seminars.teachable.com/p/21-cfr-part-11-saas-cloud-eu-gdpr
Timestamp: 2020-07-16 13:51:52
Document Index: 533628018

Matched Legal Cases: ['art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11', 'art 11']

21 CFR Part 11, SaaS/Cloud, EU GDPR | World Compliance Seminars
21 CFR Part 11, SaaS/ Cloud, EU GDPR
14- Aug at 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes
Join us for a webinar on August 14 for a discussion of the webinar
This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, 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.
• How to write a Data Privacy Statement
• What the regulations mean, not just what they say
• Avoid 483 and Warning Letters
• Understand the current industry standard software features for security, data transfer, audit trails, and electronic signatures
• How to use electronic signatures, ensure data integrity, and protect intellectual property
• SOPs required for the IT infrastructure
• Product features to look for when purchasing COTS software
• Reduce validation resources by using easy to understand fill-in-the-blank validation documents
1. What 21 CFR Part 11 means today
• Purpose of Part 11
2. What does Part 11 mean?
• Infrastructure qualification
3. Security standards
• Restrictions and logs
4. Data transfer standards
5. Audit trail standards
• High risk systems
6. Electronic approval standards
• Replacing paper with electronic forms
7. Infrastructure qualification
• How to efficiently document qualifications
• 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
• Hosting requirements
10. SOPs
• IT, QA, validation
11. Annex 11
• Comparison with Part 11
Simply select the Recorded option when registering and we will send you the link to view the recorded version.
Software vendors, hosting providers
Faculty David Nettleton
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 the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 280 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.
Live Webinar - Single Participant 60-mins
You get one log-in for the live 60-minute webinar for one participant, presentation materials and the opportunity to ask questions by phone and email
MP3 Download Online (DVD)
Recorded Access Single User
You get one log-in for the live 60-minute webinar for one participant and Access to archived recording of the entire 60-minute webinar, including the Q&A period, for 1 participant. You can log in any time of day or night.