DoubleTree by Hilton Washington DC 1515 Rhode Island Avenue, Washington DC, USA
This unique conference is designed to provide hands-on training to non-Indian small and medium sized companies interested in exploring opportunities and understanding risks of conducting drug development in India for global product approvals. Read more »
The Boston Park Plaza Hotel & Towers 50 Park Plaza at Arlington Street, Boston MA, USA
Knowing how to get your application through FDA quickly can save millions of dollars in unnecessary investment burn. Mr. DuVal, a national authority on the 510(k) program is in Silver Spring, Md. at FDA nearly twice a month negotiating 510(k) issues for his clients. Mr. DuVal will teach you the tips and tricks of the trade that he has learned in the trenches with FDA. Both attorneys also participate in the national dialogue on the proposed changes to the 510(k) program. Mr. Gardner will focus on pre-clearance/pre-approval communication, as well as the promotional issues companies face once they are on the market. Read more »
The Ritz-Carlton, Philadelphia Hotel Ten Avenue of the Arts, Philadelphia PA, USA
Nearly every computerized system used in laboratory, clinical, manufacturing settings and in the quality process has to be validated. Finding efficiencies without weakening the quality position is essential. Read more »
Online Event, Palo Alto CA
Why Should You Attend:
This session explores proven techniques that reduce validation project time, often to one-third. Learn efficient documentation strategies for computer system validation and how to increase overall system productivity. The 10-step risk-based validation approach is detailed so that the specific documents for a validation project are understood. Explore methods to decrease resource requirements, and make documentation more manageable and understandable. Read more »