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:
Superior reliability performance of your products can significantly improve brand and company reputation and boost customer acceptance. But several challenges still remain – short product development timeframes, inadequate testing timeframe and small sample sizes available for reliability testing. 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 »
Online Event
Palo Alto CA
Why Should You Attend:
Reliability is the final proof of efficiency and efficacy of a product. During this training, you will discover why statistical reliability predictions rarely correlate with field performance, how to make big reductions in warranty costs, how to eliminate failures during early design, how to select proper tests for production screening, how to set up accelerated life tests, how to manage reliability growth, and how to predict the product life. Read more »
Online Event
Palo Alto CA
Why Should You Attend:
Risk analysis is now required by law (GMP). Identification of device design problems prior to distribution eliminates costs associated with warranties, product recalls, and product validation. Read more »
Online Event
Palo Alto CA
Why Should You Attend:
It is important that companies align their corrective action process to business objectives in order to drive permanent solutions through their organizations. Often, companies fail in their capacity to manage corrective action. Read more »
Online Event
Palo Alto CA
Why Should You Attend:
When developing new products, it is imperative that manufacturers develop reliability specifications and utilize methods to predict and verify that those reliability specifications will be met. This presents a difficult challenge in many industries with short product cycles and compressed product development timeframes. Read more »