FDA`s Low-Risk Device Policy and the Impact on Mobile Medical Device Applications 2016 is a webinar that covers topics such as:
- Low-risk mobile medical applications and FDA enforcement
- Mobile medical applications and classification by FDA
- An overview of FDA`s regulation of mobile apps
- When and how FDA`s general wellness/low-risk guidance should be applied
- Comparisons between the draft wellness/low-risk policy and FDA`s medical mobile application guidance
- What the draft wellness/low-risk guidance means in relation to the draft guidance for mobile applications
- Computer System Validation (CSV) methodology
- GxP systems regulated by FDA
- Validation Strategy and Planning
- System Development Life Cycle (SDLC) framework
- GAMP 5 System Classification and "V" Model
- System Risk Assessment and Mitigation
- Industry Best Practices for Implementing and Using Mobile Applications in an FDA-regulated Environment
- Potential Pitfalls for Implementing and Using Mobile Applications in an FDA-regulated Environment
FDA`s Low-Risk Device Policy and the Impact on Mobile Medical Device Applications 2016 is intended for attendees from:
- Information Technology Developers and Testers
- Information Technology Analysts
- Clinical Data Managers and Scientists
- QC/QA Managers and Analysts
- Laboratory Managers
- Analytical Chemists
- Computer System Validation Specialists
- Automation Analysts
- Business Stakeholders/Subject Matter Experts
- GMP Training Specialists
- Consultants
- Business System/Application Testers