FDA officials, Captain Brenda Stodart (CDER Director of Small Business and Industry Assistance Program), and Elias Mallis (CDRH Director Division of Industry and Consumer Education), share all the resources they have available for industry access every day. These resources include FDA web training, conferences and workshops, education series, and incredible links to pertinent information you need. Find out how you can best take advantage of learning directly from FDA during this interview with Elias and Brenda.
Aligning with an external organization through contract operations, supplier relationships, mergers and acquisitions goes beyond FDA regulated industries – and has existed for decades. Michael Taylor, co-founder and CEO of Schellingpoint, will share insight from multiple industries that he has gained through the Schellingpoint Alignment Optimization process, which is a sophisticated methodology based on the Nobel Prize winning algorithms of Thomas P. Schelling. Through the Alignment Optimization process, Michael has identified trends of obstacles and successful practices that gives us a greater chance to achieve “Right First Time” in our FDA regulated industries.
Jessica Zeller, J.D., is the newest FDA ombudsmen in a position that was created for the first time in the Office of Regulatory Affairs. In this position, Jessica serves as an impartial voice to bring FDA and external parties toward a common understanding (often referring to herself as a translator). This newest position is instrumental in bridging gaps that might have existed for decades, as the Office of Regulatory Affairs houses all of the investigators across the country.