FDA`s Low-Risk Device Policy and the Impact on Mobile Medical Device Applications 2016
14 Jun 2016
Webinar
Description
Topics
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What the draft wellness/low-risk guidance means in relation to the draft guidance for mobile applications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
Who should Attend
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
Past Events
FDA`s Low-Risk Device Policy and the Impact on Mobile Medical Device Applications 2016 - 14 Jun 2016, Webinar (60051)
Important
Please, check "FDA`s Low-Risk Device Policy and the Impact on Mobile Medical Device Applications" official website for possible changes, before making any traveling arrangements
Event Categories
Government & Global Issues: Law & Regulations
Health & Medicine: Medical device, Medical technology
