Overview
On July 10, FDA announced it would resume prioritized domestic inspections based on a rating system of the COVID-19 virus trajectory in a given state and applicable local rules and regulations. The agency will also continue to utilize alternative means, such as record review, as well as relying on self-policing requirements such as cGMPs. This webinar will address tools the agency is using to ensure industry compliance during the COVID-19 pandemic and legal authority and limitations underlying these tools. The panelists will also discuss logistical and legal challenges facing industry in the context of inspections, and ways for industry to respond to these challenges.
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Speakers
Kalah Auchincloss, SVP, Regulatory Compliance & Deputy General Counsel, Greenleaf Health, Inc.
Jack C. Garvey, Chief Executive Officer, Compliance Architects LLC
Moderated by Neeraj Pai, Partner, Sidley Austin LLP
sponsor
KALAH AUCHINCLOSS is Senior Vice President, Regulatory Compliance and Deputy General Counsel at Greenleaf Health, LLC. She has more than a decade of food and drug legal, policy, and regulatory experience at FDA, on Capitol Hill, and in the private sector. Ms. Auchincloss spent six years at FDA, most recently as Deputy Chief of Staff for two FDA Commissioners: Dr. Robert Califf and Dr. Scott Gottlieb. As Deputy Chief of Staff, she worked with senior FDA leadership to manage crises, develop policy decisions, implement communications strategies, and liaise with the Department of Health and Human Services, the White House, and other agencies. Ms. Auchincloss was also a primary point of contact in the immediate Office of the Commissioner for the six FDA Centers and other components of the Commissioner’s Office. She has also served in FDA’s Center for Drug Evaluation and Research (CDER) as a regulatory counsel in the Office of Regulatory Policy, and as Director of CDER’s Office of Unapproved Drugs and Labeling Compliance in the Office of Compliance, leading a team of more than 50 staff working on pharmacy compounding, unapproved drugs, over-the-counter drugs, and other enforcement issues. Before joining FDA, Ms. Auchincloss was an associate at the law firm Foley Hoag LLP, in the firm’s health care practice group. She holds a BA with honors from Williams College, a JD with honors from Georgetown University Law Center, and an MPH from Harvard University.
JACK C. GARVEY is the founder and CEO of Compliance Architects LLC, a premiere consulting and advisory firm specializing in innovative quality, regulatory and compliance solutions for FDA-regulated manufacturers. As both a chemical engineer and practicing attorney, Jack helps life sciences companies navigate complex issues and challenges found at the intersection of science, engineering, business and law. Jack possesses over 30 years of hands-on technical, operational, quality, regulatory and legal experience with leading life science companies including Johnson & Johnson, Accenture, C.R. Bard, Ciba-Geigy, BASF Corporation and Ayerst Laboratories. Known for creative, “outside-the-box” thinking, Jack uses innovative, pragmatic approaches, grounded in established principles of food and drug law and regulation, to resolve the most complicated compliance and enforcement issues facing FDA-regulated industry. Jack is known for his savvy, no-nonsense approach to FDA compliance, rooted in the belief that FDA enforcement risk can be mitigated, and business performance supported – with hard work, sufficient investment and innovative approaches.
NEERAJ D. PAI is a partner in Sidley Austin LLP’s Food, Drug and Medical Device Compliance and Enforcement practice. His practice focuses on representing life science companies in connection with government investigations, enforcement proceedings, and litigation. These investigations and enforcement proceedings involve a range of matters, including marketing practices, product safety and reporting, good manufacturing practices, and civil and criminal violations of the Federal Food, Drug and Cosmetic Act (FDCA), as well as violations of the False Claims Act. Prior to joining Sidley, Raj worked in the FDA’s Office of Chief Counsel from 2008 to 2012. During his tenure, he worked closely with the FDA’s Office of Criminal Investigations (OCI), the Department of Justice, and other federal agencies responsible for investigating, prosecuting, and resolving criminal enforcement actions and related civil False Claims Act cases involving drugs, medical devices, and biological products. Raj has experience handling cases involving a wide array of issues, including marketing and promotional activities, reporting obligations, import issues, unapproved new drugs, adulterated food products, reporting requirements, smuggling, and fraud. During his time at FDA, Raj was appointed as a Special Assistant United States Attorney by the Department of Justice and assisted in the indictment and successful prosecution of cases at both the federal and state level involving adulterated and misbranded foods, drugs, devices, dietary supplements, and cosmetics. These cases included both felony and misdemeanor prosecutions under the FDCA. Raj also worked closely with field agents from OCI, the Federal Bureau of Investigation, U.S. Immigrations and Customs Enforcement, and other federal and state law enforcement agencies during the course of criminal investigations. In addition, Raj developed training materials and taught courses on food and drug law to OCI Agents. Before entering government, Raj worked in private practice in Washington, DC, representing individuals and Fortune 500 corporations in a variety of matters, with a focus on tax controversy, transfer pricing, government investigations, and internal investigations.Virtual Learning FAQ
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