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Beckman Coulter to Host BioFlorida | Miami
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4/13/2016
When: 04/13/2016
5:30 PM - 8:00 PM
Where: Beckman Coulter
11800 SW 147th Ave.
Miami, Florida  33196
United States
Contact: BioFlorida


Online registration is closed.
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Online registration is now closed but you may register onsite.

Members: $30

Non-Members: $50

Students: $20


 

Impact of Latest Regulatory Trends on

Medical Device Companies

 

Join the BioFlorida SE Chapter and have industry experts answer

your regulatory questions.Register today and join life science

professionals in your region.

 

WEDNESDAY, APRIL 13th

5:30 pm - 8:30 pm

 

 

 

111800 SW 147th Ave.

Miami, FL 33196

Click here tomap directions.

Park in front of Building 4 and enter through Main Entrance.

 

Please allow extra time for traffic.

You won't want to miss out on thisProgram!

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AGENDA

 

5:30 pm - 6:00 pm

Registration & Networking

 

6:00 pm - 6:05 pm

Welcome & Introductions

Gina Alexis, President, The Alexis Group Consultants, Inc. &

Chair, BioFlorida, SE Chapter

 

TOPICS &CONFIRMEDSPEAKERS

 

6:05 pm - 6:15 pm

Beckman Coulter Overview

Peter Soltani, Senior Vice President & General Manager for the

Hematology/Urinalysis Business Unit

Beckman Coulter

 

6:15 pm - 6:35 pm

False Claims Act (FCA)

Timothy Moore, Senior Associate, Shook Hardy & Bacon

 

6:35 pm - 6:55 pm

FDA Regulation of Medical Apps

Edgar Asebey, Partner, Jones Day

 

6:55 pm - 7:15 pm

FDA's Proposed Regulation of Laboratory Developed Tests (LDTs)

Anthony Dennis, Staff Regulatory Affairs Specialist, Beckman Coulter

 

7:15 pm - 7:35 pm

FDA Inspection Readiness for Medical Device Manufacturers

Braulio Ortiz, Principal,BioTeknica, Inc.

 

INDUSTRY PANEL AND Q&A

 

7:35 pm - 8:00 pm

 

PANEL MODERATORS

ChadDenlinger, Director Manufacturing Engineering,

Beckman Coulter&

Nicholas Gonzalez, Staff Quality Engineer,

Beckman Coulter

 

8:00 pm - 8:05 pm

Closing Remarks & Adjournment

Gina Alexis, The Alexis Group Consultants, Inc.&Chair, BioFlorida,SE Chapter

 

8:05 pm - 8:30 pm

Additional Networking & Adjourn

 

 

SIGNATURE SPONSOR

 

EVENT SPONSOR

 

 

TO REGISTER

Clickhere

 

$25 BioFlorida Members

$45 Non-Members

$15 Students

 

WALK-INS WELCOME

(additional $5 charge at door)

 

Online registration will close on Tuesday, April 12th at noon.


 





BioFlorida, Inc. | 901 NW 35th Street | Boca Raton, FL 33431
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