RAPS - This course has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.
Overview
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.
Webinar Takeaways
- 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
- Data Privacy Statement
- End
Who Will Benefit
- GMP, GCP, GLP, regulatory professionals
- QA/QC
- IT
- Auditors
- Managers and directors
- Software vendors, hosting providers
Faculty David Nettleton
FDA Compliance Specialist
Computer System Validation
Roseville, California Area
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 300 mission critical laboratory, clinical, and manufacturing software implementation projects. His most recent book is Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates, which provides fill-in-the-blank templates for completing a COTS software validation project.
1.5 RAC CREDITS
RAPS - This course has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.
World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria
