FDA`s New Draft Guidance on Software and Device Changes and the 510(k)

Description

FDA`s New Draft Guidance on Software and Device Changes and the 510(k) is a webinar that covers topics such as: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FDA`s New Draft Guidance on Software and Device Changes and the 510(k) is intended for: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

Future Events

FDA`s New Draft Guidance on Software and Device Changes and the 510(k) 2020

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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