22 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries
2023
Webinar
Key Topics
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
Who should Attend
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
Past Events
22 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries - 2023, Webinar (75884)
21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries - 11 Feb 2022, Webinar (94940)
CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries 2026
Important
Please, check "CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries" official website for possible changes, before making any traveling arrangements
