FDA`s New Draft Guidance on Software and Device Changes and the 510(k) 2018

  • 12 Oct 2018
  • Webinar

Description

FDA`s New Draft Guidance on Software and Device Changes and the 510(k) 2018 is a webinar that covers topics such as:

  • Software Application changes for software used in conjunction with medical devices
  • Medical Device changes
  • FDA Enforcement
  • FDA Guidance Documents
  • Flowcharts for decision-making related to specific changes:
  • New 510(k) submission
  • Technology, Engineering and Performance
  • Labeling
  • Q&A
  • Materials

FDA`s New Draft Guidance on Software and Device Changes and the 510(k) 2018 is intended for:

  • IT Developers
  • Information Technology (IT) Analysts
  • QC/QA Managers and Analysts
  • IT Support Staff
  • Analytical Chemists
  • Clinical Data Managers and Scientists
  • Compliance Managers and Auditors
  • Quality Managers, Chemists and Microbiologists
  • Automation Analysts
  • Lab Managers and Analysts
  • GMP Training Specialists
  • Computer System Validation Specialists
  • Regulatory Affairs Personnel
  • Business Stakeholders using Computer Systems regulated by FDA
  • Interns working at the companies listed above
  • Consultants in the Life Sciences and Tobacco Industries

Past Events

Important

Please, check "FDA`s New Draft Guidance on Software and Device Changes and the 510(k)" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Internal Audit & Compliance, Quality assurance
Government & Global Issues: Law & Regulations
Technology: Information Technology (IT)

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