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What To Consider and How to Format Succinct and Comprehensive 510(k)s
This Webinar is over| Date | Aug 24, 2017 |
| Time | 11:00 AM EDT |
| Cost | $399.00 |
|
Online
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Product Format: Live Webinar
Speaker: David Lim
Conference Date: Aug 24, 2017
Time: 12: 00 pm EST
Duration: 240 minutes
Live Session + $399
Recorded Session + $399
DVD + $419
Live & Recorded Session + $549
Live Session & DVD + $559
Recorded Session & DVD + $559
Corporate Live 1-3-Attendees + $799
Corporate Live 1-6-Attendees + $1199
Transcript (Pdf) + $398
Live & Transcript (Pdf) + $548
Recorded & Transcript (Pdf) + $548
DVD & Transcript (Pdf) + $558
Description:
This seminar will discuss what to consider and how to prepare for premarket notification 510(k)sand submit to the FDA. The speaker will walk you through how to format a succinct and comprehensive 510(k) package to increase submission quality and to facilitate the review process in a streamlined manner.
You will leave the workshop empowered in preparing for your next 510(k) submissions.
Why Should You Attend?
A premarket notification [510(k)] is the most common regulatory pathway to bring some medical devices into the US market.
The 510(k) premarket submission is made to the US Food and Drug Administration (FDA) to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device).
This seminar will discuss what to consider and how to prepare for the 510(k) submission package while ensuring 510(k) submission quality to prevent avoidable mistakes and delays and saving significant resources.
It is imperative that medical device industry quickly recognizes the recent changes in the510(k) process, and understand and adapt to the recent changes/requirements.
Areas Covered In This Seminar:
Four Hour Session (Morning and Afternoon)
Morning 12:00 PM – 2:00 PM
• Laws, Regulations, and Definition
• Overview of 510(k) Program and Changes
• 510(k) Regulatory Requirements
• Review of Relevant and Applicable Guidance Documents and Standards
• Systematic Methods to Increase 510(k) Submission Quality
Afternoon 2:30 PM – 4:30 PM
• Quality System Regulations
• How to Format a Succinct and Comprehensive 510(k) Submission
• 510(k) Contents
• Common Pitfalls and How to Prevent Them: Dos and Don’ts
• What to Ensure While Preparing for a 510(k) Application
• Responding to FDA’s Request for Additional Information.
• Resolving Different Opinions and Interpretations: Dos and Don’ts
Who will benefit:
• Medical Device Quality and Compliance Professionals
• Pharmaceutical Compliance Professionals
• Quality
• Regulatory Affairs
• CEOs
• VPs
• Attorneys
• Clinical Affairs
• R&D
• Consultants
• Contractors/Subcontractors
• Anyone Interested in the 510(k) Matters
Call us: +1-800-935-3714 or
Mail us: cs@onlineaudiotraining.com
Not able to attend the audio session? We will provide you with a replay of the session, or you can request a DVD recording.
Speaker: David Lim
Conference Date: Aug 24, 2017
Time: 12: 00 pm EST
Duration: 240 minutes
Live Session + $399
Recorded Session + $399
DVD + $419
Live & Recorded Session + $549
Live Session & DVD + $559
Recorded Session & DVD + $559
Corporate Live 1-3-Attendees + $799
Corporate Live 1-6-Attendees + $1199
Transcript (Pdf) + $398
Live & Transcript (Pdf) + $548
Recorded & Transcript (Pdf) + $548
DVD & Transcript (Pdf) + $558
Description:
This seminar will discuss what to consider and how to prepare for premarket notification 510(k)sand submit to the FDA. The speaker will walk you through how to format a succinct and comprehensive 510(k) package to increase submission quality and to facilitate the review process in a streamlined manner.
You will leave the workshop empowered in preparing for your next 510(k) submissions.
Why Should You Attend?
A premarket notification [510(k)] is the most common regulatory pathway to bring some medical devices into the US market.
The 510(k) premarket submission is made to the US Food and Drug Administration (FDA) to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device).
This seminar will discuss what to consider and how to prepare for the 510(k) submission package while ensuring 510(k) submission quality to prevent avoidable mistakes and delays and saving significant resources.
It is imperative that medical device industry quickly recognizes the recent changes in the510(k) process, and understand and adapt to the recent changes/requirements.
Areas Covered In This Seminar:
Four Hour Session (Morning and Afternoon)
Morning 12:00 PM – 2:00 PM
• Laws, Regulations, and Definition
• Overview of 510(k) Program and Changes
• 510(k) Regulatory Requirements
• Review of Relevant and Applicable Guidance Documents and Standards
• Systematic Methods to Increase 510(k) Submission Quality
Afternoon 2:30 PM – 4:30 PM
• Quality System Regulations
• How to Format a Succinct and Comprehensive 510(k) Submission
• 510(k) Contents
• Common Pitfalls and How to Prevent Them: Dos and Don’ts
• What to Ensure While Preparing for a 510(k) Application
• Responding to FDA’s Request for Additional Information.
• Resolving Different Opinions and Interpretations: Dos and Don’ts
Who will benefit:
• Medical Device Quality and Compliance Professionals
• Pharmaceutical Compliance Professionals
• Quality
• Regulatory Affairs
• CEOs
• VPs
• Attorneys
• Clinical Affairs
• R&D
• Consultants
• Contractors/Subcontractors
• Anyone Interested in the 510(k) Matters
Call us: +1-800-935-3714 or
Mail us: cs@onlineaudiotraining.com
Not able to attend the audio session? We will provide you with a replay of the session, or you can request a DVD recording.
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