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Data Integrity and Privacy - compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
What 21 CFR Part 11 means today
- Purpose of Part 11
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 the software vendor and hosting provider
- Evaluation criteria
- Hosting Requirements
SOPs
- IT, QA, validation
- Software development
Annex 11
- Comparison with Part 11
EU GDPR
- Data Privacy Statement
Overview 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.
Who should attend?
- GMP, GCP, GLP, regulatory professionals
- QA/QC Departments
- IT Departments
- Auditors
- Managers and directors
- Software vendors, hosting providers
Why should you attend?
- 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
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.