This 3-Hour webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations, and You'll learn about the various computer system.
validation deliverables and how to document them through the entire process, also learn about what must be done to ensure the system remains in a validated state.
We will also review recent trends in FDA enforcement and highlight key areas of CSV that are being scrutinized most heavily.
Why should you Attend: This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations.
This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do.
It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. We will discuss the phases within the SDLC, and how these form the basis for any CSV project. The importance of the sequence of steps will also be covered.
You should also attend to learn the key areas most scrutinized by FDA during inspection to prepare for future audits.
Areas Covered in the Session:
Computer System Validation (CSV)
System Development Life Cycle (SDLC) Methodology
Good "variable" Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice, Good Clinical Practice (GCP)
GAMP 5 System Classification
Functional Requirements Specification
Configuration and Custom Coded Solutions
Installation Qualification (IQ) Testing
Operational Qualification (OQ) Testing
Performance Qualification (PQ) Testing (User Acceptance Testing/UAT
Validation Summary Report
Operational Maintenance for Validated Systems
Policies and Procedures
Organizational Change Management (OCM)
Periodic System Review
Disaster Recovery and Business Continuity Planning
FDA Recent Inspection Trends and Key Areas of Focus
- Information Technology (IT) Analysts
- IT Developers
- IT Support Staff
- QC/QA Managers and Analysts
- Clinical Data Managers and Scientists
- Compliance Managers and Auditors
- Lab Managers and Analysts
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders using Computer Systems Regulated by FDA
- Regulatory Affairs Personnel
- Consultants in the Life Sciences and Tobacco Industries
- Interns Working at the Companies Listed Above
• Information Technology (IT) Analysts
• IT Developers
• IT Support Staff
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Compliance Managers and Auditors
• Lab Managers and Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders using Computer Systems Regulated by FDA
• Regulatory Affairs Personnel
• Consultants in the Life Sciences and Tobacco Industries
• Interns Working at the Companies Listed Above