Using Q-Submission to Most Effectively Prepare for an FDA 510(k) Submission 2015

  • 02 Jul 2015
  • Online Event

Description

Using Q-Submission to Most Effectively Prepare for an FDA 510(k) Submission 2015 is a webinar that covers topics such as:

  • Definitions
  • Laws and Regulations
  • 510(k) Program
  • Device Classification and Predicates
  • Applicable Regulatory Requirements
  • When are 510(k)s Required
  • 510(k) Requirements, Contents and Format
  • Q-Submission and How to Effectively Use It
  • Addressing e-Copy and RTA Policy Requirements
  • Substantial Equivalence: Factors to Consider and Special Considerations
  • Common Mistakes and How to Prevent Them
  • Applicable Standards and Guidance
  • Responding to FDA’s Request of Additional Information
  • De Novo Process Pursuant to FDASIA 2012
  • Best Practices for a Q-submission; 510(k) Preparation, Submission and Clearance
  • Resolving Different Opinions and Interpretations
  • Conclusions
  • Speaker’s Practical, Actionable and Sustainable Solutions

Using Q-Submission to Most Effectively Prepare for an FDA 510(k) Submission 2015 is intended for:

  • R&D
  • RA
  • CROs
  • QA/QC/QS
  • Contractors/subcontractors
  • Consultants
  • Anyone interested in 510(k) matters
  • Senior management

Past Events

Important

Please, check "Using Q-Submission to Most Effectively Prepare for an FDA 510(k) Submission" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Science: Life Sciences & Biology

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