Trends for Computer System Validation, Medical Device Compliance and FDA Enforcement 2019 is a webinar that covers topics such as:
- System Development Life Cycle (SDLC) Methodology
- Computer System Validation (CSV)
- 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
- "GxP" - Good Manufacturing, Laboratory and Clinical Practices (GMPs, GLPs, GCPs)
- Validation Strategy/Planning that will take into account the system risk assessment and system categorization (GAMP V) processes
- Data Retention/Archival to ensure security, integrity and compliance
- Critical Training and Organizational Change Management (OCM)
- Policies and Procedures
- FDA Response to Change
- FDA Regulatory Trends
- Recent trends in technology that need to be addressed in the CSV approach
- Recent FDA findings for companies in regulated industries
- Industry Best Practices
Trends for Computer System Validation, Medical Device Compliance and FDA Enforcement 2019 is intended for:
- Information Technology Managers
- Information Technology Analysts
- QC/QA Analysts
- QC/QA Managers
- Clinical Data Scientists
- Clinical Data Managers
- Compliance Managers
- Analytical Chemists
- Automation Analysts
- Laboratory Managers
- Manufacturing Supervisors
- Manufacturing Managers
- Computer System Validation Specialists
- Supply Chain Specialists
- Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
- GMP Training Specialists
- Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
