This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful strategies for medical devices, including definitions and classifications, elements of regulatory strategy, sources of regulatory intelligence, selection of development and product clearance/approval pathways.

Date : 20th April 2017 to 21st April 2017

Place : United States, San diego

Website :http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900900SEMINAR?channel=mailer&camp=Seminar&AdGroup=allconferencealerts_April_2017_SEO

Contact Person:John Robinson

Description:

This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful strategies for medical devices, including definitions and classifications, elements of regulatory strategy, sources of regulatory intelligence, selection of development and product clearance/approval pathways.

This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful strategies for medical devices, including definitions and classifications, elements of regulatory strategy, sources of regulatory intelligence, selection of development and product clearance/approval pathways. will be held in San diego,United States on date 2017-04-21

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Deadline for abstracts/proposals : 19th April 2017

Keynote Speakers : Thomas E. Colonna Founder, Biotech Consultant LLC Dr. Thomas E. Colonna earned a bachelor of science in microbiology from the University of Sciences in Philadelphia (formerly the Philadelphia College of Pharmacy and Science), a Ph.D. in molecular biology from the Johns Hopkins University, and a law degree from the Georgetown University Law Center. In addition to his consulting activities, Dr. Colonna is the Director of the MS in Regulatory Science and MS in Food Safety Regulation programs a

Conference Highlights :Day 1 Schedule Registration & Breakfast 8.30 am - 9.00 am Lecture 1: Overview of FDA Medical Device Regulation 9 am - 10.30 am Break 10.30am - 11.00 am Lecture 2: Overview of FDA Medical Device 510(k) Premarket Notification Process 11.00 am - 12.30 pm Lunch 12.30 pm - 1.30 pm Lecture 3: Overview of FDA Medical Device PreMarket Application Process 1.30 pm - 3.00 pm Break 3.00 pm - 3.30 pm Lecture 4: Overview of FDA Device Manufacturing Issues 3.30 pm - 5.00 p

Venue :Four Points By Sheraton San Diego Downtown 1617 1st Avenue San Diego, California, 92101 United States

Check the event website for more details.