Online Safety Community

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

Export to Outlook or iCal (.ics)

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.

Comment Wall

Comment

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

Join Online Safety Community

Attending (1)

Take our poll!

Take our poll!

Latest Activity

Mark Nilson posted events
10 hours ago
Joseph Wilcox posted a blog post

Aseptic Processing Overview and Validation

This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a high-level overview of microbiology in regards to cleanroom environmental monitoring and the associated impact to product and patient health and safety.This course will also review the guidance…See More
11 hours ago
Training Doyens posted events
16 hours ago
Premier Safety is now a member of Online Safety Community
yesterday

Forum

What % of Dollars should be bugeted for All Safety Training for a "Heavy Equipment Road Construction" company with 100 employees? 1 Reply

I have been at a Highway and Road Construction company for six months. I am developing a (first) complete training program. I am the 1st full time safety hire for this company. I need to develop a…Continue

Started by JTurpening. Last reply by Jen McDade yesterday.

Technology and Safety 1 Reply

What are the most useful tools to have at your fingertips? -Toolbox Talks-JSA-JHA-Daily Reports, etc. What is falling through the cracks that could be an easy fix? Safety Managers, Coordinators and…Continue

Tags: safety

Started by Drew stone. Last reply by Jen McDade on Friday.

Important of Warning sign 1 Reply

Warning sign is a type of traffic sign that guide a hazard ahead on the road. Having proper warning sign on the road provide a healthy environment.Continue

Tags: Signs, Workplace, Safety, Sign, Warning

Started by healthandsafetysigns. Last reply by Jen McDade Jan 14.

Workers paticipation in safety management 2 Replies

Workers paticipation in safety management is the aspect which is required to be implemented in the OHSAS 18001 2007 version. , I invite our experience community members to share their views on the…Continue

Tags: management, safety, in, paticipation, Workers

Started by SafetyRaja. Last reply by Tara safe Dec 27, 2018.

How to improve safety culture of factories 4 Replies

How to improve safety culture of factories having mostly contract and casual ever changing workers for whom training and monitoring both are major issues. Such qorkers are mainly meeting accidents in…Continue

Started by Harkant Dave. Last reply by Jen McDade Dec 24, 2018.

Badge

Loading…

© 2019   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service