February 21, Main Program: Global Product Safety and Quality – New FDA Initiatives and Tools By Director of Office of Regional Operations, Office of Regulatory Affairs FDA, Chicago District Director Scott MacIntire (7:30-8:30 PM )

Gain an inside view: this presentation will focus on new FDA strategic plans, initiatives, and tools to meet today’s global challenges and rapidly changing environment providing insight into the significance of these changes to different stakeholders. No matter your company’s area of expertise, help your company thrive. Everyone in your organization with a role in Regulatory Affairs, Research and Development, and Strategic Planning deserves to take part in this event. Whether you are a professional who works in pharmaceutical, biologics, devices, diagnostics, or food industries, this presentation is for you!

We live in a nation that increasingly relies on other countries to produce the food, drugs, cosmetics, and devices we use in our daily lives.  Nearly two-thirds of the fruits and vegetables–and 80% of seafood–eaten domestically come from outside the U.S.  Half of all medical devices used in this country are imported, while 80 percent of the active pharmaceutical ingredients in medications sold here are manufactured elsewhere. FDA-regulated products account for about 10% of all imports into the U.S., arriving from more than 300,000 facilities in 150 different countries. Learn how FDA is poised to meet the challenges presented by a rapidly changing environment and a global marketplace through new FDA initiatives and tools. Rather than just intercepting harmful products, FDA is pushing to anticipate and prevent the arrival of harmful products before they reach our borders.

Changing Paradigm – from a reactive system to a preventive one. The  global outlook outlined in FDA’s new strategic plan, “Pathway to Global Product Safety and Quality” described the FDA paradigm shift to overcome the challenges of globalization today and in the future. This presentation – Global Product Safety and Quality: New FDA Initiatives and Tools is an update that outlines the FDA’s plan for meeting the unique, and complex, demands of globalization. Stay current, be proactive, reduce risk, improve your compliance programs, and improve your competitive edge. If you had the opportunity to talk with the Director of Office of Regional Operations, what would you want to ask? What would you want to know? Facing a FDA challenge? Get the FDA perspective. Gain real-world advice from an FDA expert with a wealth of experience and expertise to help you gain the inspiration and strategies to help you to make decisions with greater clarity and better outcomes – to make the right choices now and in the future.

Scott MacIntireMr. MacIntire currently serves as the director of the U.S. Food and Drug Administration’s Chicago District Office. The office is responsible for conducting investigations on over 6,000 registered firms and annually screening 500,000 import shipments in the state of Illinois. Firms include food, medical devices, imports, drug firms, biologic firms, and veterinary medicine. He recently supervised a large portion of the 2012 Office of Regulatory Affairs reorganization while serving as the Acting Director of the Office of Regional Operations, and has served many years as the chair of the Center for Veterinary Medicine field committee. Mr. MacIntire has worked for FDA for 22 years, and previously worked for the Virginia Department of Health and the Virginia Department of Agriculture. He graduated from East Tennessee State University with a Bachelor’s Degree in Environmental Health in 1982.


Excerpts from: Pathway to Global Product Safety and Quality, Executive Summary by Dr. Margaret Hamburg, Commissioner of Food and Drugs. For decades, FDA has been a recognized world leader in product safety standards. But as the agency looks to the future, it can no longer rely on the historical tools, activities and strategies to regulate products…In order to cope with the magnitude of the fundamental shifts on the horizon, the agency is committed to substantially and fundamentally revising its approach to global product safety and quality. Over the next decade, FDA will transform itself from a domestic agency operating in a globalized world to a truly global agency fully prepared for a regulatory environment in which product safety and quality know no borders…To achieve this transformation, FDA is

developing an international operating model that relies on enhanced intelligence, information sharing, data-driven risk analytics, and the smart allocation of resources through partnerships.

The Strategic Plan’s new approach rests on four core building blocks:

1) FDA, in close partnership with its foreign counterparts, will assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world.

2) With these coalitions, FDA intends to develop a global data information system and network in which regulators worldwide can regularly and proactively share real-time information and resources across markets.

3) FDA will continue to expand its capabilities in intelligence gathering and use, with an increased focus on risk analytics and thoroughly modernized IT capabilities.

4) FDA will effectively allocate agency resources based on risk, leveraging the combined efforts of government, industry, and public- and private-sector third parties.

The New global outlook outlined in FDA’s new strategy, “Pathway to Global Product Safety and Quality”: The essence of this strategy marries creative international coalitions with cutting-edge investigative tools to continue to provide the consistently high level of safety and quality assurance the public expects—and deserves. FDA will continue to partner with other federal agencies, the states, and nations across the world. It will also look to Congress to modernize its antiquated authorities so that FDA’s legal tools keep pace with globalization. http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/UCM262528.pdf

Excerpts from: The Speech, Remarks at GMP by the Sea by Carolyn Becker, J.D., Senior Regulatory Counsel, Office of the Commissioner Food and Drugs.  “A new strategy is needed to cope with the magnitude of the fundamental global shifts on the horizon and ensure the safety and quality of FDA-regulated products imported into the U.S. Our current tools and approaches will not be sufficient to provide the needed assurance of safety and quality as globalization continues to increase in the future. FDA must substantially and fundamentally revise its approach…What is envisioned for the future is a public health safety net for consumers around the world that is created, supported, and maintained by global alliances of regulators…The Pathway strategy will enable us to take these efforts to the next level…This is a long-term strategy. As you may be aware, Commissioner Hamburg recently created a directorate focused on grappling with the truly global nature of today’s world so that FDA can move from being a regulator of domestic products to one overseeing a worldwide enterprise. The new Office of Global Regulatory Operations and Policy will be led by a Deputy Commissioner who will provide broad direction and support to FDA’s Office of Regulatory Affairs and Office of International Programs. The mandate of this new office is to make FDA’s response to globalization challenges and import safety a top priority in years to come, and to ensure that FDA fully integrates its domestic and international programs to best promote and protect the health of the public. This Office will also be responsible for implementing the Pathway strategy. As initial steps, the Office will establish a framework and approach for broader data sharing and use of third parties. It will also work rapidly to partner with foreign counterparts to create global coalitions of regulators”. Remarks at GMP by the Sea by Carolyn Becker, J.D., Senior Regulatory Counsel, Office of the Commissioner Food and Drug Administration, August 8, 2011  http://www.fda.gov/NewsEvents/Speeches/ucm267671.htm


The American Society for Quality (www.asq.org), is a not-for- profit organization, and the world’s largest organization dedicated to quality. ASQ is a global community of people dedicated to quality who share the ideas and tools to make our world work better. With millions of individuals and organizational members of the community in 150 countries, ASQ has the reputation and reach to bring together the diverse quality champions who are transforming the world’s corporations, organizations, and communities to meet tomorrow’s critical challenges. ASQ is headquartered in Milwaukee, Wisconsin, and organized into local sections and sector-specific divisions.  Our ASQ Northeastern Illinois 1212 is a section dedicated to the promotion and advancement of quality tools, principles, and practices in the workplace and community and has over 800 individual members (plus corporate members: ASQ Enterprise and Site members). It is one of the top rated sections in the society and it meets on a regular basis to help their members become leaders of quality – to share ideas, experiences, and knowledge. Our members are dedicated Quality Professionals who are constantly working on self-improvement knowledge that can be applied in the workplace. Our Section provides them with a diverse network committed to assist them with their individual and organizational learning and is a primary source for their individual and organizational excellence. American Society for Quality, Northeastern Illinois 1212’s meetings are always free and members and non-members are always welcome Join us on Thursday February 21st, 2013 at the Arboretum Club, 401 W. Half Day Rd., Buffalo Grove IL.  asq1212reservations@yahoo.com

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