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FDA Device Regulation 2017

Zoom in  Zoom out Publish date: 2017-04-05   Hits: 0   Status: Status
Date 2017-04-20 to 2017-04-21
City San Diego
Address Four Points By Sheraton San Diego Downtown, 1617 1st Avenue San Diego, California
Exhibition hall Four Points By Sheraton San Diego Downtown
Sponsor Netzealous
Undertaker Netzealous - GlobalCompliancepanel

Event Description
 Overview:

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.

Why should you attend :

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.

Areas Covered in the Session:

  • Describe the elements impacting the definition and classification of medical devices
  • Determine the points to consider in the development of a regulatory strategy
  • Define the tools for regulatory strategy development
  • Recognize sources of regulatory and competitive intelligence
  • Identify the elements of a regulatory plan
  • Apply regulatory principles to develop a regulatory plan

 

Who will benefit:

  • Regulatory professionals working in the medical device field

 

Agenda:

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 pm

Lecture 5:

Q & A

5.00 pm - 5.30 pm

 

Day 2 Schedule


Registration & Breakfast

8.30 am - 9.00 am

Lecture 1:

Overview of In Vitro Diagnostic Regulation

9 am - 10.30 am

 

Break

10.30am - 11.00 am

Lecture 2:

Overview of Biomedical Software Regulation

11.00 am - 12.30 pm

 

Lunch

12.30 pm - 1.30 pm

Lecture 3:

Overview of FDA Medical Device Post-Market Surveillance

1.30 pm - 3.00 pm

 

Break

3.00 pm - 3.30 pm

Lecture 4:

Overview of Device Regulatory Strategies

3.30 pm - 5.00 pm

Lecture 5:

Q & A

5.00 pm - 5.30 pm

 

Speaker:

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 at Johns Hopkins University.

Price:

 

Register now and save $200. (Early Bird)

 

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

 

Until March 15, Early Bird Price: $1,295.00 from March 16 to April 18, Regular Price: $1,495.0

 

Registration Link - 

http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900900SEMINAR?biowww_april_2017_SEO 

 


Contact information
Contact: John Robinson
Address: NetZealous LLC, 161 Mission Falls Lane
Mobile:
Tel:
Fax:
Email:
QQ: 94539
 
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