Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals 2017

Start Date : April 27, 2017
End Date : April 28, 2017
Time : 9:00 am to6:00 pm

Phone : 800-447-9407
Email : support@globalcompliancepanel.com

Location :
Courtyard Raleigh-Durham Airport 2001 Hospitality Ct, Morrisville, NC 27560, United States

Website

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:

  1. History and background of U.S FDA Laws and Regulations
  2. Classify Your Device
  3. Choose the Correct Premarket Submission for your device
  4. Compile the Appropriate Information for your Premarket Submission
  5. Author and Prepare your Premarket Submission
  6. Submit your Premarket Submission to the FDA
  7. Interact with FDA Staff during Review and Approval
  8. 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.

Areas Covered in the Session:

 

Who will benefit:

 

 

Agenda:

Lecture 1:

An overview of U.S. FDA Premarket Regulations

Lecture 2:

Premarket Notification 510(k)

Lecture 3:

Premarket Notification 510(k) – continue

Lecture 4:

Premarket Notification 510(k) – continue

 

Day 2 Schedule

Lecture 1:

Premarket Approval (PMA)

Lecture 2:

Premarket Approval (PMA) – continue

Lecture 3:

Investigational Device Exemption (IDE)

Lecture 4:

Post Market Requirements for Medical Devices

 

 

Speaker:

Subhash R Patel,

Regulatory Affairs & Quality Compliance Consultant, MD Reg Consulting, LLC ,

 

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.

He is a Fellow of world’s renowned Regulatory Affairs Professional Society (RAPS) and holds professional recognition as a Regulatory Affairs Certified (RAC) form RAPS. He also holds professional certification as Certified Quality Auditor (CQA) and Certified Quality Engineer (CQE) form American Society for Quality (ASQ). His educational background includes BS degree in Mechanical Engineering and BS degree in Chemistry. He founded MD Reg Consulting, LLC based in New Jersey, USA to serve medical device industry clients in all aspects of global regulatory affairs and specific to their needs.

 

 

Location: Raleigh, NC Date: April 27th & 28th, 2017 and Time: 9:00 AM to 6:00 PM

 

Venue: Courtyard Raleigh-Durham Airport

Address:  2001 Hospitality Ct, Morrisville, NC 27560, United States

 

Price:

 

Register now and save $200. (Early Bird)

 

Price: $1,295.00 (Seminar Fee for One Delegate)

 

Until March 20, Early Bird Price: $1,295.00 From March 21 to April 25, Regular Price: $1,495.00

Register for 5 attendees   Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

 

 

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

 

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com     

 

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Organized by

Organized by globalcompliancepanel

NetZealous DBA as GlobalCompliancePanel ,
Online Event , NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA 94539, USA

Tel: Event Manager
Mobile: 800-447-9407
Email: support@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com


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