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2-day In-person Seminar on “Combination Products: How to Get Your Combination Product Approved and onto the US Marketplace” at San Francisco

Event Details

2-day In-person Seminar on “Combination Products: How to Get Your Combination Product Approved and onto the US Marketplace” at San Francisco

Time: October 30, 2014 at 9am to October 31, 2014 at 6pm
Location: San Francisco, CA, USA
Street: 1300 Veterans Blvd. - South San Francisco, California 94080 USA
City/Town: San Francisco
Website or Map: http://bit.ly/CombinationProd…
Phone: 18004479407
Event Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda
Organized By: GlobalCompliancePanel
Latest Activity: Sep 2, 2014

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Event Description

Summary of the workshop:

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.

This course provides the participant the ability to understand the entire FDA Combination Product Process and how to navigate through the FDA Combination Product Process to get your Combination Product onto the US marketplace.

Learning Objectives from this Workshop:

Learn about the FDA Office of Combination products

Learn what a Combination Product is

Learn the FDA Combination Product Process

How to navigate the FDA Combination Product system

Mode of action and primary mode of action

How to prepare a Request for Designation

User Fees for Combination products

GMPs for Combination products

Post-Approval Modifications

 

Meet your Expert:

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. He has worked in every major segment of the industry-research, quality assurance, regulatory affairs, manufacturing and clinical.

RAC Credits: 12

Date: October 30th & 31st, 2014 

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

Location: San Francisco, CA

Venue: Courtyard San Francisco Airport/Oyster Point Waterfront

Venue Address:  1300 Veterans Blvd. - South San Francisco, California 94080 USA

Venue Link: http://www.marriott.com/hotels/travel/sfoop-courtyard-san-francisco-airport-oyster-point-waterfront/

Registration: Open Enrolment

Price: $1295.00

Delivery: Face-to-Face event

Until September 26, Early Bird Price: $1,295.00

From September 27 to October 28, Regular Price: $1,495.00

Organizer:
GlobalCompliancePanel imparts knowledge of best practices in industry to guarantee effective implementation of compliance programs for meeting regulatory demands. The key focus of GlobalCompliancePanel is to provide extensive and quality training for risk management, regulatory compliances, corporate governance and quality management.

Provider:

GlobalCompliancePanel

                John Robinson

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

                Phone: 800-447-9407

                Fax: 302-288-6884

                Email: support@globalcompliancepanel.com

                Website: www.globalcompliancepanel.com

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