21 CFR Part 11 Compliance for Computer Systems Regulated by FDA 2018 covers topics such as:
- System Development Life Cycle (SDLC) Methodology
- Computer System Validation (CSV)
- Validation Strategy
- Good "Variable" Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
- GAMP 5 "V" Model
- System Risk Assessment
- Electronic Records/Electronic Signatures (ER/ES)
- CFR Part 11
- Policies and Procedures
- Security, Access, Change Control and Audit Trail
- Industry Best Practices and Common Pitfalls
- Training and Organizational Change Management
21 CFR Part 11 Compliance for Computer Systems Regulated by FDA 2018 brings together:
- Information Technology Developers and Testers
- Information Technology Analysts
- Clinical Data Managers and Scientists
- QC/QA Managers and Analysts
- Laboratory Managers
- Analytical Chemists
- Manufacturing and Supply Chain Managers and Analysts
- Automation Analysts
- GMP Training Specialists
- Computer System Validation Specialists
- Business System/Application Testers in FDA-Regulated Functional Areas
- Business Stakeholders/Subject Matter Experts in FDA-Regulated Functional Areas
- This seminar will also benefit any consultants working in the tobacco or life science industries who are involved in computer system implementation, validation and compliance.