Overview
Join FDLI on an in-depth analysis of considerations in contract manufacturing partnerships for medical product production. During this webinar, speakers will discuss regulatory compliance and accountability when delegating product manufacturing to third parties. Speakers will highlight current industry issues such as supply chain matters, quality control management, and intellectual property (IP) ownership. This webinar will conclude with potential solutions to these issues, including continuous manufacturing and creating comprehensive quality system models to ensure compliance and product security.
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Speakers
Bryan J. Coleman, Senior Director, Pharmaceutical & Device Consulting, EAS Consulting Group
Teresa Gorecki, Practice Lead, Compliance Architects LLC
Paula R. Katz, Of Counsel, Covington & Burling LLP
Howard R. Sklamberg, Partner, Arnold & Porter LLP
Moderated by Alan G. Minsk, Partner, Arnall Golden Gregory, LLP
BRYAN J. COLEMAN is Senior Director for Pharmaceuticals and Medical Devices at EAS Consulting Group where he facilitates compliance for pharmaceuticals, OTC, medical device and combination products. He spent five years at FDA, including roles as a chemist, and then a consumer safety officer (CSO/Investigator), where he performed a wide variety of field inspection work in finished pharmaceutical and API (Rx/OTC/Veterinary Medicines) for GMPs and PAI, BIMO/GCP, medicated animal feed operations, medical device, cosmetics, food and dietary supplement manufacturing, packaging/labeling and distribution facilities. Additionally, he conducted product complaint and recall surveillance activities. While at FDA, Bryan served on FDA’s Foreign Inspection cadre for drug inspection work. He was the lead on FDA inspection management programs, supplier due diligence and corporate audit conformance. Immediately prior to joining EAS, he was Senior Manager of Quality Programs and Projects at Altria Client Services where he was the lead for the internal quality and supplier audits program, quality system development and provided clinical study oversight. Prior to Altria, he spent nearly 14 years as the Director of Quality and Compliance for Research and Development at Pfizer Consumer Healthcare, where he oversaw all aspects of quality for multiple sites engaged in development, clinical supply production/release, clinical study oversight, CAPAs and regulatory conformance. Bryan has practical industry experience with pharmaceuticals, medical devices, dietary supplements and tobacco/ENDS products/processes in the areas of development, improvement, and implementation of sound Quality Systems that are efficient, sustainable, and compliant with FDA regulations. He recently retired from a 30-year career in the Virginia Army National Guard, attaining the rank of Colonel.
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.
HOWARD R. SKLAMBERG is a partner at Arnold & Porter where he counsels clients on a wide range of compliance and enforcement issues related to US Food and Drug Administration (FDA) regulation and policy. His experience is rooted in a deep understanding of US and foreign food, drug and medical devices law and policy, and is able to 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, Mr. 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, Mr. Sklamberg was FDA’s top enforcement official. He oversaw the agency’s inspections, enforcement, recalls, and import operations programs. Mr. 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, Mr. Sklamberg served as a prosecutor in the US Attorney’s Office in Washington, DC, and in the Public Integrity Section of the Criminal Division at the Department of Justice.
ALAN G. MINSK is a partner and leader of the Food and Drug Practice Team at Arnall Golden Gregory LLP. Alan is licensed to practice in Georgia and Washington, DC. He works out of AGG’s Atlanta and Washington offices. Alan is recognized by Chambers USA America’s Leading Lawyers for Life Sciences, Regulatory/Compliance and has been selected for inclusion in the International Who’s Who of Life Sciences Lawyers from 2013 – 2020. Nominees are selected based upon comprehensive, independent survey work with both General Counsel and private practice lawyers worldwide. He serves as general counsel of The Sharing Alliance Inc., a pharmaceutical trade organization focused on compliance with the Prescription Drug Marketing Act and sample accountability. Alan focuses his practice on advising pharmaceutical, biologic, medical device, cosmetic, food (including dietary supplements and medical foods) companies, on all legal and regulatory matters relating to the US Food and Drug Administration. For companies in the pre-approval phase, he counsels on the following areas: clinical trial issues, communications with the FDA during the review process, imports and exports, regulatory strategy including 505(b)(2) new drug applications, orphan drug designation, Fast Track and Breakthrough Therapy designations, combination product determinations, market exclusivity, premarket notification (510(k)) submissions, premarket approval applications, and pre-approval discussions. In addition, Alan works with life science companies and venture capital firms on regulatory diligence matters involving acquisitions, divestitures, regulatory opinion letters, co-promotions and licensing agreements. He also drafts and reviews agreements relating to clinical trials, quality, and contract manufacturing. He conducts in-house training on FDA and fraud and abuse topics. Alan’s client base is primarily focused on early-stage to mid-sized life science companies, where he must clearly articulate the legal and regulatory issues for consideration while also recognizing the client’s business realities and needs. He currently serves on a number of editorial boards for professional publications, including the RAPS Focus magazine and the Food and Law Drug Institute’s Food and Drug Law Journal.Virtual Learning FAQ
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