The Center for Professional Innovation & Education, Los Angeles, CA
March 7 & 8, 2011
Who Should Attend This course will be most valuable to medical device/product professionals who need a firm understanding of how to gain FDA approval for combination products. The course is geared toward personnel that are newer to the industry or need to gain perspective of how to develop a successful combination product. Engineers, managers, supervisors, scientists, technicians, and other personnel involved in product development, manufacturing, quality assurance, or regulatory affairs that do not have an in-depth knowledge of Combination Products will benefit from this course. 
Learning Objectives
Upon completion of this course, attendees will have an understanding of the framework for the specific FDA Combination Product regulations required to speed product to market. The course will also provide an overview of medical device, drug, and biologic product regulations to the extent that they relate to combination products. Emphasis will be placed not only on the regulatory aspects of product development, but also on overall medical product strategy and the development environment. Instructional emphasis is focused on taking an efficient, cost-effective approach to obtaining FDA approval on your Combination Product, thus avoiding unnecessary spending and wasted time. Exercises will be used to reinforce the key concepts. Attendees will receive extensive course notes that can be used as reference material once the course is completed.
Course Description This course covers current FDA regulatory compliance with respect to developing and marketing Combination Products. A focus is placed on relevant aspects of FDA regulations as well as the practical aspects of getting the Combination Product to market. Several example products will be highlighted to provide practical, hands-on instruction. The first part of the course provides general context for the overall topics surrounding combination products. Later, a more in-depth discussion on implementation within a complete combination product development environment is presented. FDA’s regulations, guidance documents, and on-line informational resources will be highlighted and used throughout the course.
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