Overview
A thorough understanding of post-inspection procedures and potential actions can reduce the likelihood of additional enforcement against manufacturers including seizures, injunctions, litigation, and criminal prosecution. This webinar will enumerate what to expect after an FDA inspection; distinguish FDA post-inspection notices, such as 483 forms, warning letters, and close-out letters; discuss best practices to effectively communicate with FDA and demonstrate accountability to shareholders and consumers; and provide key tips for avoiding the most serious enforcement actions.
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Speakers
Hannah R. Bornstein, Partner, Nixon Peabody LLP
Teresa Gorecki, Practice Director, Compliance Architects LLC
Stephanie M. Haggerty, Senior Corporate Counsel, Pfizer
Beth P. Weinman, Counsel, Ropes & Gray LLP
Moderated by Maya P. Florence, Partner, Skadden, Arps, Slate, Meagher & Flom LLP
HANNAH R. BORNSTEIN is a litigator, trusted advisor, and the deputy practice group leader of Nixon Peabody’s Government Investigations & White Collar Defense group. She is also a member of the firm’s Life Sciences team. She counsels life sciences companies, including drug, device, and food manufacturers, through a range of FDA compliance, enforcement, and litigation matters. She is experienced in matters involving the False Claims Act; the Food, Drug and Cosmetic Act (FDCA); and the Anti-Kickback Statute. She represents clients in high-stakes crisis matters, including responding to government inquiries or investigations conducted by the FDA, United States Attorney’s Offices, and the Department of Justice, among others. She also counsels clients on FDA regulatory and compliance questions, and works with Nixon Peabody’s transactional deal teams in providing advice and analysis on FDA-related due diligence matters.
MAYA P. FLORENCE is a partner at Skadden, Arps, Slate, Meagher & Flom LLP where she represents pharmaceutical, biotechnology and medical device manufacturers in Food and Drug Administration (FDA) enforcement and regulatory matters, federal and state government civil and criminal investigations, and litigation. Ms. Florence has extensive experience in matters involving advertising and promotion issues, GMP/QSR compliance, fraud and abuse enforcement, federal and state anti-kickback laws, HIPAA and False Claims Act defense. Her work often involves assisting clients in balancing the competing demands and navigating risks involved in concurrent investigations by federal authorities and state attorneys general. Ms. Florence also frequently provides legal and strategic advice to FDA-regulated companies, as well as hospitals and other health care providers, regarding fraud and abuse and compliance in several contexts, including FDA regulatory compliance, Corporate Integrity Agreement implementation, internal investigations and strategic transactions. She has significant experience developing, implementing and assessing corporate compliance programs for pharmaceutical and medical device companies. In addition, Ms. Florence frequently conducts due diligence and strategic counseling in connection with life sciences and health care industry transactions, and has advised clients on more than 150 transactional matters. Ms. Florence has repeatedly been selected for inclusion in Chambers USA: America’s Leading Lawyers for Business. In addition to her practice, Ms. Florence is a member of the firm’s Women’s Initiative Committee, which works to promote the retention and advancement of women in the firm.
TERESA GORECKI comes to Compliance Architects® from Johnson & Johnson, Janssen Pharmaceuticals, where she was most recently Vice President, Market Quality. At Johnson & Johnson, Teresa was one of J&J’s top Quality professionals, known for her ability to manage inspections and remediate and improve deficient operations. Teresa had senior level roles across all three sectors within Johnson & Johnson: Pharmaceuticals, Consumer Products and Medical Devices. Teresa is one of Compliance Architects® lead subject matter experts, and has primary responsibility for strategic client engagements. Teresa received her BS in Microbiology, with a minor in Chemistry from South Dakota State University.
STEPHANIE M. HAGGERTY is Senior Corporate Counsel in Pfizer’s Global Supply Legal Group where she practices as a GxP Regulatory attorney advising clients in Pfizer’s manufacturing, medical, safety, pharmacovigilance, and pharmaceutical sciences groups. Stephanie advises her clients on GxP and regulatory compliance, market actions and regulatory enforcement, and assists clients prepare for GMP and pharmacovigilance inspections and related remediation strategies. Prior to joining Pfizer in 2008, Stephanie practiced Environmental Law at Beveridge & Diamond, P.C. in New York, New York and at K&L Gates in Newark, New Jersey. Stephanie holds a JD from Pace University School of Law, a MS from the University of Georgia, and a BS from the State University of New York College of Environmental & Forest Biology.
BETH P. WEINMAN is a member of Ropes & Gray’s life sciences regulatory and compliance practice group, and focuses her practice on FDA regulation and enforcement of laws governing pharmaceuticals, biologics, medical devices and foods, including dietary supplements. Beth represents clients in False Claims Act (FCA) and Federal Food, Drug, and Cosmetic Act (FDCA) investigations, and other enforcement actions before state and federal regulators, and also represents clients in administrative litigation matters. Beth also provides counseling on issues related to marketing practices, current good manufacturing practices, good clinical practices, compounding, medical product development and approval, and product recalls and withdrawals. Prior to joining Ropes & Gray, Beth spent nearly eight years as Associate Chief Counsel for Enforcement within FDA’s Office of Chief Counsel. In that role, she worked closely with FDA’s Office of Criminal Investigations, the Department of Justice and other government agencies to investigate and, when appropriate, prosecute alleged violations of the FDCA and related crimes under Title 18 (including, e.g., mail fraud, wire fraud, healthcare fraud, and conspiracies to defraud). She also worked on numerous parallel and independent FCA investigations involving FDA regulated drugs and devices, including biologics. Before starting at FDA, Beth spent more than seven years as an associate in the litigation department of a large New York law firm, where, among other matters, she represented a number of pharmaceutical companies in government investigations and securities class action lawsuits.Virtual Learning FAQ
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