GAMP® 5 as applied to FDA software validation - strategies to avoid warning letters 2015

Topics

• Review of FDA software validation requirements
• Outline of FDA regulations as applied to software
• Strategies on how to avoid the most common problems
• Why validation makes good business sense
• Advice on successful validation project staffing
• The GAMP® approach
• GAMP® 5 as applied to FDDA software validation
• GAMP® 5 Principles
• Using GAMP® 5 to cut validation costs

Who should Attend

• Policy makers fof software validation and software quality
• System owners - responsible for keeping individual systems in validation
• QA / QC managers, executives and personnel
• Software development life cycle (SDLC) personnel
• Validation specialists
• IT / IS managers and personnel
• Consultants
• Software quality reviewers