2014 - Webinar On 510(k) Updates: Trends, New Strategy and FDA Clearance

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 including recent 510(k) trends and updates.
Areas Covered in the Session :
Statute(s) And Regulations
Definitions
Device Classification
Identifying Predicates: Key Factors
510(k) Program
When a 510(k) Is 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
Common Mistakes for 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 (PASS)
Conclusions
Who Will Benefit:
Regulatory Affairs Teams
Research & Development Teams
QA/QC/QS
CROs
Consultants
Contractors / Subcontractors
Senior Management
Anyone interested in 510(k) matters
For bookings and more information contact
Compliance Trainings
5939 Candlebrook Ct,
Mississauga, ON L5V 2V5,
Canada
Customer Support : #416-915-4458
Email : support-AT-compliancetrainings.com