3-Hour Virtual Seminar on 21 CFR Part 11 Guidance for Electronic Records and Electronic Signatures in FDA-Regulated Industries

Seminar Agenda:

Session 1:

• FDA Regulatory Oversight
• Computer System Validation (CSV)
• System Development Life Cycle (SDLC) Methodology
• Good “Variable”Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))

Session 2:

• Validation Strategy
• System Risk Assessment
• GAMP 5 “V”Model
• 21 CFR Part 11
• Electronic Records/Electronic Signatures (ER/ES)
• Security, Access, Change Control and Audit Trail

Session 3:

• Validation Documentation
• 7 Most Common Problems with Validation
• FDA Audit Preparation
• Policies and Procedures
• Training and Organizational Change Management
• Industry Best Practices and Common Pitfalls

Who Should Attend:

• Information Technology Analysts
• Information Technology Managers
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Managers
• Manufacturing Supervisors
• Supply Chain Specialists
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
• Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
• Auditors Engaged in Internal Inspection