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Compliance with 21 CFR Part 11 and AI
- How Part 11 works with AI
- Which data and systems are subject to Part 11 and Annex 11
- Reduce validation resources by using easy to understand fill-in-the-blank validation documents
- 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
- What 21 CFR Part 11 means today
- Purpose of Part 11
- How Part 11 works with AI
- What does Part 11 mean?
- SOPs
- System features
- Infrastructure qualification
- Validation
- Security standards
- Roles
- Usernames and passwords
- Restrictions and logs
- Data transfer standards
- Deleting data
- Encryption
- 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
- Validation
- 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
- SOPs
- IT, QA, validation
- Software development
- Annex 11
- Comparison with Part 11 end
Overview of the webinar
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 validate software employing Artificial Intelligence (AI). 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?
- GMP, GCP, GLP, regulatory professionals
- QA/QC
- IT Professionals
- Auditors
- Managers and directors
- Software vendors, hosting providers
Why should you attend?
It explains how to validate software employing Artificial Intelligence (AI). 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.
Faculty - Mr.David Nettleton
Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, 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. 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. He has completed more than 225 mission critical laboratory, clinical, and manufacturing software implementation projects. Services are available to guide companies to create and maintain the systems and procedures required to pass regulatory audits: product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.