Trends for Computer System Validation, Medical Device Compliance and FDA Enforcement 2019
15 Mar 2019
Webinar
Description
Topics
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
Who should Attend
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
Past Events
Trends for Computer System Validation, Medical Device Compliance and FDA Enforcement 2019 - 15 Mar 2019, Webinar (82293)
Important
Please, check "Trends for Computer System Validation, Medical Device Compliance and FDA Enforcement" official website for possible changes, before making any traveling arrangements
