22 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries is a webinar that 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)
- 21 CFR Part 11
- Policies and Procedures
- Security, Access, Change Control and Audit Trail
- Industry Best Practices and Common Pitfalls
- Training and Organizational Change Management
22 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries is intended for:
- IT Developers
- Information Technology (IT) Analysts
- QC/QA Managers and Analysts
- IT Support Staff
- Compliance Managers and Auditors
- Clinical Data Managers and Scientists
- Computer System Validation Specialists
- Lab Managers and Analysts
- Business Stakeholders using Computer Systems regulated by FDA
- GMP Training Specialists
- Consultants in the Life Sciences and Tobacco Industries
- Regulatory Affairs Personnel
- College students attending schools and studying computer system validation, regulatory affairs/matters (related to FDA) or any other discipline that involves adherence to FDA regulatory requirements
- Interns working at the companies listed above