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Seminar on Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA

Event Details

Seminar on Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA

Time: May 5, 2016 at 8am to May 6, 2016 at 5:30pm
Location: Courtyard Boston Logan Airport
Street: 225 William F. McClellan Highway
City/Town: Boston
Website or Map: http://bit.ly/preparing-prema…
Phone: 1-800-447-9407
Event Type: conference
Organized By: John Robinson
Latest Activity: Apr 21, 2016

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Event Description

Overview:
This workshop style training course is designed based on 30 year of regulatory affairs experience in preparing more than 150 successful U.S. FDA submissions for major medical device companies. In these 2 days, the following essential elements of U.S FDA premarket submissions will be covered:
• History and background of U.S FDA Laws and Regulations
• Classify Your Device
• Choose the Correct Premarket Submission for your device
• Compile the Appropriate Information for your Premarket Submission
• Author and Prepare your Premarket Submission
• Submit your Premarket Submission to the FDA
• Interact with FDA Staff during Review and Approval
• Complete the Establishment Registration and Device Listing
Why should you attend?

The U.S. FDA regulatory 510(k) clearance and Premarket Approval (PMA) process is considered a most stringent and complex. Only a good knowledge of U.S. FDA laws, regulations, and requirements is not sufficient to win a clearance/approval. You are required a proper training on how to set and state regulatory arguments for your device in a most convincing manner to the U.S. FDA reviewer. This 2 days training seminar will walk you through building process of a reader’s friendly but resounding premarket submission and also give you tips and suggestions on how to work effectively with the U.S. FDA officials during review and approval process of your submission.
Who Will Benefit:
• Marketing Professionals
• Research & Development - Product Managers
• Quality Assurance and Quality Engineers
• Project Managers responsible for United States
• Buyers/Purchasing Professionals
• Students majoring in Regulatory Affairs
Speaker:
Subhash R Patel
Subhash Patel is an accomplished Regulatory Affairs Professional offering 30 plus year of experience in authoring, preparing and submitting more than 150 successful premarket submissions to U.S. FDA.
Location: Boston, MA Date: May 5th & 6th, 2016 Time: 08:00 AM to 05:30 PM

Venue: Courtyard Boston Logan Airport
Address: 225 William F. McClellan Highway - Boston, Massachusetts 02128 USA

Price: $1,295.00 (Seminar fee for One Delegate)
Register now and save $200. (Early Bird)
Until March 31, Early Bird Price: $1,295.00 from April 01 to May 03, Regular Price: $1,495.00
Quick Contact:
NetZealous DBA as GlobalCompliancePanel
Phone: 1-800-447-9407
Fax: 302-288-6884
Email: support@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com/
Registration Link - http://bit.ly/preparing-premarket-submissions-Boston

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