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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: 18004479407
Event Type: conference
Organized By: NetZealous DBA as GlobalCompliancePanel
Latest Activity: Mar 14, 2016

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Event Description

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
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 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

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. He brings his expert knowledge and hands-on experience in developing a robust premarket submission that secures clearance or approval from U.S. FDA. He offers valuable tips and suggestions on what works and what doesn’t form his own experience. He has presented numbers of technical papers at conferences and conducted plentiful training seminars in various countries.

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