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