2-day In-person Seminar on Marketing Products without Getting Hammered by FDA at Sydney, Australia

Event Details

Time: September 21, 2015 at 9am to September 22, 2015 at 6pm
Location: Hilton Sydney
Street: 488 George Street, Sydney, Australia 2000
City/Town: Sydney
Website or Map: https://www.globalcompliancep…
Phone: 18004479407
Event Type: food, fda, medical, device, defence, and, navy, aerospace, mining
Organized By: John Robinson
Latest Activity: Aug 4, 2015

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Event Description

Overview

With this seminar you will learn how to navigate FDA's legal requirements and its interpretations for enforcement purposes. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This becomes a new factor in trying to stay within FDA's legal corral.

This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion.

Areas Covered in the Session:

FDA's legal authority and Constitutional limitations
FDA requirements and exemptions
FDA guidance documents, such as for social media, direct -to-consumer advertising, message formatting and providing risk/benefit information
Warning Letters

Who Will Benefit:

Regulatory Affairs
Quality Assurance
Manufacturing
FDA Consultants and Legal Counsel

Speaker:

Casper (Cap) Uldriks, through his firm "Encore Insight LLC," brings over 32 years of experience from the FDA. As an investigator, he was responsible for countless 483s, scores of Warning Letters, injunctions, individual seizures, mass seizures and was coined by industry as FDA's "Darth Vader." He inspected foods, drugs, methadone clinics and clinical investigators, but specialized in the FDA's medical device program. He served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements for FDA. His comments are candid, straightforward and of practical value.

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