22 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

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