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).
Why Should You Attend:
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..Areas Covered in the Webinar:
- 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
Agenda:
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 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
Who Will Benefit:
- GMP, GCP, GLP, regulatory professionals
- QA/QC
- IT
- Auditors
- Managers and directors
- Software vendors, hosting providers
Course Provider
David Nettleton,
