Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR

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.

Areas Covered in the Session
What 21 CFR Part 11 means today
Purpose of Part 11
What does Part 11 mean?
System features
Infrastructure qualification
Security standards
Usernames and passwords
Restrictions and logs
Data transfer standards
Deleting data
Audit trail standards
Types of data
High risk systems
Electronic approval standards
Electronic signatures
Single sign-on
Replacing paper with electronic forms
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
SaaS/Cloud hosting
Responsibilities for software vendor and hosting provider
Evaluation criteria
Hosting requirements
IT, QA, validation
Software development
Annex 11
Comparison with Part 11
Learning Objectives
Which data and systems are subject to Part 11 and Annex 11
How to write a Data Privacy Statement
What the regulations mean, not just what they say
Avoid 483 and Warning Letters
Requirements for local, SaaS, and cloud hosting
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
Who Will Benefit
GMP, GCP, GLP, Regulatory Professionals
Managers and Directors
Software Vendors, Hosting Providers
Speaker Profile
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.

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