Overview
Major international emergencies such as the COVID-19 pandemic and the ongoing conflict in Ukraine have led to supply chain disruptions for FDA-regulated companies. During this webinar, speakers will discuss: 1) specific impacts of supply chain disruptions on FDA-regulated industry; 2) findings from the FDA’s 2021 100-day review of supply chains and reports on outcomes one year later; 3) ways that companies can mitigate risks posed by unexpected shortages or problems getting access to components of regulated products from third-party manufacturers; 4) federal efforts to stimulate domestic manufacturing of critical medical products and other FDA-regulated components; and 5) how organizations have rethought and rebuilt their supply chains to be more agile, efficient, and sustainable.
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Speakers
Christina Anderson Mooney, Senior Legal Director, Medtronic
Amy Norris, Executive Counsel, Clif Bar & Company and Member, FDLI Board of Directors
Howard R. Sklamberg, Partner, Life Sciences & Healthcare Regulatory, Arnold & Porter LLP
Moderated by Winston Kirton, Partner, BakerHostetler
CHRISTINA ANDERSON MOONEY serves as the Senior Legal Director of the FDA/Life Sciences team in the Enterprise Legal Regulatory group at Medtronic. She counsels internal business and functional clients on a variety of medical device matters including compliance with FDA’s Quality System Regulation, product risk management, recalls, inspections, clinical trial compliance and data transparency, and advertising and promotion activities, including the management of off-label promotion risk. Christina has worked for Medtronic for twelve years. Prior to joining Medtronic, Christina was an associate with the FDA & Life Sciences Practice Group in the Washington, D.C. office of King & Spalding, where she counseled pharmaceutical, biotechnology, and medical device companies on a broad range of FDA enforcement matters. 
WINSTON S. KIRTON advises both domestic and international companies that are facing regulatory challenges involving products and services regulated by the FDA, including biopharmaceutical, medical device, food and dietary supplements, in connection with corporate transactions, research and development, manufacturing and supply chain, and commercial regulatory and compliance matters. He also advises clients regarding legal disputes related to third-party contract manufacturing relationships, third-party supplier relationships and alliance-partner relationships. Due to his significant experience with the complex FDA requirements, Winston is able to guide clients and their most significant deals through all aspects of FDA regulatory due diligence. He provides comprehensive advice to clients facing legal and regulatory challenges with products and services regulated by the FDA, including on how to address the FDA regulatory process. Winston accumulated in-depth international legal and business life sciences experience through a variety of in-house positions at several large multinational biopharmaceutical companies, particularly in the areas of quality and compliance, regulatory affairs, compliance and ethics and legal affairs. This allows him to provide clients with a holistic view of their regulatory matters when combined with his knowledge of the regulatory process for pharmaceuticals, medical devices, foods and dietary supplements. Winston previously served as the head of compliance and ethics, while based in London, for a multinational U.S. pharmaceutical company, and was responsible for business units comprised of Latin America, Central and Eastern Europe, Middle East-Asia-India, China and the Pacific Rim regions.
AMY NORRIS is Executive Counsel and Senior Vice President, Legal for Clif Bar & Company Amy advises the company on legal and operational matters, including regulatory compliance, food safety, food labeling, advertising, litigation, and domestic and international business issues. Amy oversees the operation of the legal department and actively manages the risk management and regulatory compliance groups. Amy has been with Clif Bar for eleven years. Prior to joining Clif Bar, Amy was in private practice for 10 years. Amy has spoken on Proposition 65, food labeling, food advertising, and food law litigation. She co-authored an article entitled “When Regulation Can Lead to Litigation: Top Issues in Food & Dietary Supplements”, and contributed a chapter of the American Health Lawyers Association’s Enterprise Risk Management Handbook for Healthcare Entities.
HOWARD R. SKLAMBERG is a partner at Arnold & Porter where he counsels clients on a wide range of compliance and enforcement issues related to U.S. Food and Drug Administration (FDA) regulation and policy. His experience is rooted in a deep understanding of U.S. and foreign food, drug and medical devices law and policy, and can guide domestic and international clients through the regulatory challenges they face. Areas of expertise include inspections and warning letters, investigations, civil and criminal enforcement, medical product applications and clinical research, food and hemp regulation, imports, the development of FDA policy and FDA-related legislation, and business transactions involving FDA-regulated companies. Prior to entering private practice, Sklamberg held a variety of roles at the FDA from2010 to 2017, including Deputy Commissioner for Global Regulatory Operations and Policy; Director of the Office of Compliance, Center for Drug Evaluation and Research; Deputy Associate Commissioner for Regulatory Affairs; and Director in the Office of Enforcement. While at the agency, he directed an office of over 5,000 employees in more than 200 offices, laboratories and import facilities across the United States, Asia, Europe, and Latin America. As Deputy Commissioner, Sklamberg was FDA’s top enforcement official. He oversaw the agency’s inspections, enforcement, recalls, and import operations programs. Sklamberg also led FDA’s international program, including its agreements and cooperation with foreign regulators, harmonization initiatives, and oversight over the global supply chain. He also interacted with and testified before Congress on behalf of the agency, co-led FDA’s implementation of the FDA Food Safety Modernization Act and was the lead official at FDA on a variety of issues including cannabis and hemp, counterfeit drugs, and FDA’s Mutual Recognition Agreement with the European Union. Earlier in his career, Sklamberg served as a prosecutor in the U.S. Attorney’s Office in Washington, D.C., and in the Public Integrity Section of the Criminal Division at the Department of Justice.Virtual Learning FAQ
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