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Combination Products

Zoom+  Zoom- Publish date: 2014-06-27   Author: Albert A. Ghignone   Hits: 80
This course provides a comprehensive understanding of the FDA Combination Product system. Participants receive a foundation of knowledge about the FDA Office of Combination Products, the FDA Combination Product system, Combination Product submissions, and
                    FDA

This Seminar is Pre- approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

http://bit.ly/CombinationProducts

Overview:

This course provides a comprehensive understanding of the FDA Combination Product system. Participants receive a foundation of knowledge about the FDA Office of Combination Products, the FDA Combination Product system, Combination Product submissions, and the scientific and regulatory principles involved.

Participants will learn what a Combination Product is; learn about mode of action and primary mode of action, how to prepare a Request for Designation submission, Combination Product user fees, GMP for Combination Products and how to interact with the FDA Office of Combination products. 

Why should you attend?

A must course for those who have Combination Products or are anticipating that they will have Combination Products. This course explains the entire FDA Combination Product system and how to navigate the FDA Combination Product system. If your concern is getting your Combination Product on the US marketplace this course is a must attend for you.

Who Will Benefit:

Regulatory Affairs Personnel

Research Personnel

Quality Personnel

Clinical Personnel

Manufacturing Personnel

Personnel who require an understanding of the FDA Combination Product Process

ABOUT SPEAKER –

Albert A. Ghignone, MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and generic drugs.

Location:  San Francisco       Date: August 14th & 15th 2014    Time: 9 AM to 6 PM PDT 

Venue: WILL BE ANNOUNCED SOON

Price: $1,295.00 

Discount:

Register now and save $200. (Early Bird)

Until June 20, Early Bird Price: $1,295.00 
from June 21 to August 12, Regular Price: $1,495.00

Contact Information:
Event Coordinator

Toll free: 1800 447 9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com

Website: https://www.globalcompliancepanel.com

LIVE CHAT SUPPORT - http://www.globalcompliancepanel.com/chat/client.php

Event Link: http://bit.ly/CombinationProducts

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA 

 
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