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.....

Date : 27th April 2017 to 28th April 2017

Place : United States, Raleigh

Website :http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900778SEMINAR?channel=mailer&camp=Seminar&AdGroup=allconferencealerts_April_2017_SEO

Contact Person:John Robinson

Description:

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.....

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..... will be held in Raleigh,United States on date 2017-04-28

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Deadline for abstracts/proposals : 25th April 2017

Keynote Speakers : 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 "

Conference Highlights :Lecture 1: An overview of U.S. FDA Premarket Regulations • History and background of U.S FDA Laws and Regulations • How to Classify Your Device • Choose the Correct Premarket Submission for your device Lecture 2: Premarket Notification 510(k) • Applicable Laws, Regulations and Requirements for 510(k) • Decide Type of 510(k) • Compile the Appropriate Information for 510(k) • Format and Content of your 510(k) Lecture 3: Premarket Notification 510(k) - continue • Sugges

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

Check the event website for more details.