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Webinar On The FDA 510(k) and Q-Submission: Best Practices

Event Details

Webinar On The FDA 510(k) and Q-Submission: Best Practices

Time: February 4, 2015 from 1pm to 2pm
Location: Online
Street: 5939 Candlebrook Court
City/Town: Mississauga
Website or Map: https://compliancetrainings.c…
Phone: 4169154458
Event Type: webinar
Organized By: Compliance Trainings
Latest Activity: Dec 12, 2014

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Event Description

On Going Christmas Offers: Offer valid till 1 st January 2015

1. Register an attendee for Single Live:

Get 10% of on every Registration

First 10 attendees will receive recording Access to the webinar for No Additional Cost

For Coupon Code call customer support:  416-915-4458

2. Register your Group for Corporate Live:

Get 15% of on every Registration

Every group registrant will receive Recording Access to the webinar for No Additional Cost

For Coupon Code call customer support: 416-915-4458

3. Unlimited viewing for 4 days

4. The discounted amount will appear after entering the Coupon Code in the Secure Check Out Page

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

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

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1358

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