Webinar On 510(k) Preparation, Submission and Clearance: Dos and Don'ts

Description :

FDA recently issued final 510(k) guidance, providing FDA’s policy on the 510(k) program. 

This webinar will provide great opportunities to get familiar with how to best prepare for a 510(k) for a successful submission and clearance: in particular, recent trends including Dos and Don’ts. 

Based on speaker’s recent experience, he will discuss best practices for adequately putting your 510(k) together for your successful submission to the FDA compliant with the FDA’s eCopy and RTA policy. 

This presentation will greatly help you streamline your 510(k) preparation and submission process at your firm for maximum benefits in a least burdensome, effective manner. 

In this presentation, the speaker will share his PASS-IT solutions based on what he has learned from his own experience including his recent analysis of various different types of 510(k)s that have been recently cleared. 

This presentation is a must for regulatory professionals working in medical device industry including those who are interested in the topic.

Areas Covered in the Session :

Laws And Regulations

Definitions

Device Classification

Predicates

Recent FDA Final 510(k) Guidance

When a 510(k) Is Required

510(k) Requirements

Substantial Equivalence: Factors to Consider and Special Considerations

Addressing e-Copy And RTA Policy Requirements

Common Mistakes for eCopy and RTA Policy Requirements

Common 510(k) Pitfalls: How to Prevent Them: Dos and Don’ts

What to Ensure While Preparing for a 510(k) Application

Responding to FDA’s Request of Additional Information.

Resolving Different Opinions and Interpretations

Best Practices for 510(k) Contents and Format

PASS-IT Recommendations: Dos and Don’ts

Who Will Benefit:

Medical Device Quality and Compliance Professionals

Pharmaceutical Compliance Professionals

Quality

Regulatory Affairs

CEOs

VPs

Attorneys

Clinical Affairs

Research & Development

Consultants

Contractors/Subcontractors

Anyone Interested in the 510(k) Matters

Price tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1514