Webinar On The FDA 510(k) and Q-Submission: Best Practices
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| Description: | This webinar will provide an opportunity to get familiar with an FDA's process to communicate with the industry early in the process for sustainable 510(k) preparation and submission. This webinar is intended to discuss how to put together a pre-submission (Q-submission) to obtain FDA feedback on your proposed questions, which will be helpful and useful for your device design, preclinical and clinical study plan and design, if applicable. Areas Covered in the Session : Statute(s) And Regulations Definitions Device Classification And Predicates 510(k) Program When 510(k)s Are Required Applicable Regulatory Requirements: Biocompatibility, Software, Risk Management, etc. Pre-Submission (Q-Submission) for a 510(k): Requirements, Contents and Format Substantial Equivalence: Factors to Consider and Special Considerations Addressing e-Copy And RTA Policy Requirements Applicable Standards and Guidance 510(k) Contents And Format Common Pitfalls and How to Prevent Them What to Ensure While Preparing Your Q-Submission and a 510(k) Application Responding to FDA's Request of Additional Information. Resolving Different Opinions and Interpretations Best Practices for a Q-submission Best Practices for a 510(k) Preparation, Submission and Clearance Speaker's Practical, Actionable and Sustainable Solutions Conclusions Who Will Benefit: Regulatory Affairs Research & Development Quality Assurance Quality Control Quality System Management CROs Consultants Contractors/Subcontractors Senior management Anyone interested in 510(k) matters |
| URL: | https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1358 |
| Date: | Wednesday, February 4, 2015 |
| Time: | 6:00pm-7:00pm UTC |
| Duration: | 1 hour |
| Access: | Public |
| Category: | Webinar* |
| Created by: | Public Access |
| Updated: | Tuesday, December 16, 2014 12:17pm UTC |
| : | $249 |
| : | 4169154458 |
| : | uttam@compliancetrainings.com |
| : | Uttam Mandal |
| : | 4169154458 |
| Comments: | None |