GAMP 5 as applied to FDA software validation - strategies to avoid warning letters 2015 covers topics such as:
- 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
GAMP 5 as applied to FDA software validation - strategies to avoid warning letters 2015 brings together:
- 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
