Please check back for 2020 speakers.
2019 speakers are below:
Pamela Furman Forrest
Partner, Covington & Burling
Pamela Forrest has over 20 years of experience in advising clients on a broad range of FDA regulatory issues. Her practice focuses on FDA medical device matters, including premarket notification, premarket approval, product recalls, Medical Device Reporting (MDR), Quality System Regulation (QSR) compliance, establishment registration and device listing, labeling and promotion, import/export issues, and clinical trial requirements. Ms. Forrest frequently advises medical device manufacturers on responses to FDA enforcement actions, including Form FDA-483 observations and Warning Letters. She has extensive experience working with firms to draft written responses, develop and implement corrective actions, and prepare for re-inspection. Ms. Forrest regularly assists medical device manufacturers, investment banks, and private equity firms with complex due diligence evaluations regarding the FDA compliance status of acquisition targets. She also frequently counsels start-up medical device firms on market entry strategies, and works with firms to identify the appropriate regulatory pathway and shepherd them through the FDA regulatory process. Ms. Forrest has written and spoken extensively on various aspects of FDA regulation of medical devices, and has testified before several State legislative committees regarding medical device legal and regulatory issues.
Director- Recall Solutions, Stericycle
Chris Harvey leads a team of recall strategists and works with clients to ensure flawless implementation and customer integration throughout the entire product recall process. Chris assists in the scoping, plan development, and recall execution for a diverse set of industries, including pharmaceutical, medical device, food & beverage, and consumer products. Throughout his career, he has managed more than 1,000 recalls, including hundreds of high-profile recalls and withdrawals for the nation’s largest pharmaceutical and CPG companies. With his wide range of experience, Chris offers Stericycle clients proven and efficient solutions to challenges arising from every aspect of the recall process; from initial planning and preparation to the full scale execution of a product recall. Additionally, Chris works with numerous law firms and PR firms across all industries to help their clients mitigate recall related risk. Chris is recognized as an expert in the recall industry and routinely speaks on best practices for recall planning and execution at trade shows, conventions, and conferences. Chris is a proud graduate of Purdue University, where he earned his Bachelor’s Degree in Law and Society.
Senior Quality Systems and Compliance Consultant, King & Spalding
Eric Henry is a Senior Quality Systems and Compliance Consultant in the FDA and Life Sciences practice of King & Spalding. Eric has 28 years of experience in global quality and compliance roles (16 years in medical device leadership), with a specialization in software quality (including cybersecurity), medical device design controls, risk management, audit management, and management controls. Eric came to King & Spalding from Philips, where he was the Global Head of Quality Assurance / Quality Engineering for the Diagnostic Imaging Business Group and had responsibility for design controls, risk management, and a variety of other interim management system elements in seven business units spanning 14 sites globally. Prior to Philips, Eric led design quality assurance at Medtronic’s Diabetes Business Unit, was responsible for software design controls and general design controls effectiveness for GE Healthcare for all GE businesses worldwide, and had software quality and software design leadership responsibility at Boston Scientific and Hologic. Eric has hands-on problem-solving and organizational change management experience, as it relates to large process improvement initiatives, the defense of quality systems to third parties (e.g. FDA, notified bodies, CFDA), quality system remediation programs (including under FDA enforcement actions), and the execution of product development programs, where both quality and global compliance are mission critical. Prior to entering the medical device industry, Eric led a software quality management and program management office consulting capability in the Washington, DC area and held software design and development leadership roles in a small startup, a mid-size healthcare software company, a large financial services regulator and stock market, and a large retail organization.
Senior Director, ML Strategies
Prior to joining ML Strategies, Aaron spent 10 years with the US Food and Drug Administration, most recently as a senior policy advisor in the Center for Devices and Radiological Health where he led legislative policy development activities related to all aspects of medical device regulation and oversight. He also apprised members of Congress and their staffs about FDA policies and programs and advised multiple FDA Commissioners and other senior officials on strategy and content for meetings with Congress, industry representatives, and other stakeholders. In addition to negotiating the reauthorization of the medical device user fee program (MDUFA), Aaron led FDA’s implementation of key provisions of the 21st Century Cures Act and the FDA Reauthorization Act.
Lead Quality Systems and Compliance Consultant, King & Spalding LLP; former FDA Deputy Associate Commissioner for Regulatory Operations
Steven Niedelman serves as lead quality systems and compliance consultant to the FDA & Life Sciences practice team at King & Spalding, specializing in regulatory, enforcement and policy matters involving industries regulated by the FDA. He provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and food industries to ensure compliance with the requirements of the federal Food, Drug and Cosmetic Act. He joins King & Spalding from Crowell & Moring LLP, where he was a senior consultant in its health care group. Previously, he was executive vice-president of Quintiles Consulting. Mr. Niedelman consults with manufacturers, importers, new product developers, as well as with firms involved in or facing enforcement actions. Mr. Niedelman retired from the FDA in 2006 after a 34-year distinguished career, where he served as the Deputy Associate Commissioner for Regulatory Affairs and as Chief Operating Officer of the Office of Regulatory Affairs. He ensured consistent interpretation of FDA’s regulatory policies by directly overseeing offices at the headquarters of the Office of Regulatory Affairs (ORA), including the Office of Regional Operations, Office of Enforcement and Office of Criminal Investigations. Additionally, Mr. Niedelman assisted in the day-to-day management of FDA’s nearly 3,400 field staff responsible for investigative and laboratory operations. While at ORA, Mr. Niedelman served as the principle liaison to the Center for Devices and Radiological Health, and was a member of the Global Harmonization Task Force (GHTF) Steering Committee, FDA/Medical Device Industry Grassroots Initiative Steering Committee and the CDRH Post Market Initiative Steering Committee. He also served on the Steering Committee to the Pharmaceutical cGMP for the 21st Century” initiative as well the Counterfeit Drug Task Force. Prior to joining the Office of the Associate Commissioner, he was the Director and Deputy Director of FDA’s Office of Enforcement, where he was responsible for oversight and consistency of compliance policy, enforcement and recall activities to ensure fair implementation by FDA’s five product centers. During his tenure, Mr. Niedelman presided as the Chairman of FDA’s Compliance Policy Council. He currently participates as a member of the Medical Devices Committee at the Food and Drug Law Institute and as a member of the Editorial Review Board for FDAnews GMP publications directed at the pharmaceutical and medical device industries. Mr. Niedelman has also served as Vice President of the FDA Alumnae Association.
President, Ombu Enterprises LLC
Dan O’Leary has more than 30 years of experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. Dan is now President of Ombu Enterprises, LLC a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. He has a Masters Degree in Mathematics; is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
Founder, Compass Life Science Solutions
James Rogers, founder and head of Compass Life Science Solutions, has more than 20 years experience dealing with the compliance requirements of various standards and regulations. He has helped companies achieve compliance with GAMP, 21 CFR Parts 11, 58, 210, 211, and 820, ISO 9000, 13485 and 14971, IEC 62304, the European MDD and MDR directives, and Annex 11. His industry experience includes the manufacturing of medical devices, and implementing regulatory compliant software and datacenter services. Most recently, Rogers has been working with companies to develop compliance strategies and methodologies to support the utilization of cloud based solutions as medical devices.
Aftin Ross, Ph.D.
Senior Project Manager, Senior Science Health Advisor , All-Hazards Readiness Response and Cybersecurity Team, CDRH,
Aftin Ross is a senior project manager and senior science health advisor in the Emergency Preparedness/Operations and Medical Countermeasures program at the FDA’s Center for Devices and Radiological Health (CDRH). In this role, she leads cross-disciplinary projects related to preparedness including medical device cybersecurity, respiratory protective devices, personal protective equipment, and incident response. Regarding cybersecurity, she has been a lead in CDRH’s medical device cybersecurity efforts spearheading the execution of three FDA public workshops, serving on various interagency cybersecurity work groups, supporting numerous cross-stakeholder efforts (e.g. the 2017 healthcare cybersecurity task force), managing CDRH’s MITRE cybersecurity contract, and engaging in policy development as a member of the CDRH cybersecurity workgroup. Aftin earned a B.S. in mechanical engineering from the University of Maryland Baltimore County where she was a Meyerhoff Scholar. She completed her graduate work at the University of Michigan earning a master’s and PhD in biomedical engineering. After her graduate work, she completed a post-doctoral fellowship as a Whitaker International Fellow at the Karlsruhe Institute of Technology in Karlsruhe, Germany. In 2016, she completed the National Preparedness Leadership Initiative, an executive education program in the Harvard School of Public Health and Kennedy School of Government.
Executive Director of Medical Device Education and Training, NSF Health Sciences; former Medical Device Specialist and Senior Investigator at ORA and International Team Lead at CDRH, FDA
Robert (Rob) Ruff joined NSF International as the Executive Director of Medical Device Education and Training in December 2017. Rob has over 30 years of experience in the medical device and public health sectors. Prior to joining NSF International, Rob worked in the orthopedic device manufacturing industry and completed a long, distinguished career with the US FDA. Rob was a highly regarded district Medical Device Specialist and Senior Investigator in FDA’s Office of Regulatory Affairs (ORA), where he conducted investigations for a broad range of device technologies. During this time, he was a member of the ORA Medical Device Investigator Certification Board, where he co-developed ORA’s Level II medical device investigator certification program. From ORA, Rob was recruited by FDA’s Center for Devices and Radiological Health to lead an international team of subject matter experts tasked with the development, implementation, and maintenance of the Medical Device Single Audit Program (MDSAP). Rob’s in-depth knowledge of the MDSAP now serves as a valuable asset to NSF clients marketing products around the globe. Rob’s extensive regulatory experience includes co-authoring the MDSAP Audit Model and the Quality System Inspection Technique (QSIT). Training has been a hallmark of Rob’s distinguished career, having developed FDA’s computer-based training for QSIT, the Quality System Regulation, and the Medical Device Reporting Regulation. Mr. Ruff received many awards for his honorable service with the FDA.
Foreign Enforcement Branch, Division of International Compliance Operations, Office of Compliance, CDRH, FDA
Daniel Walter is currently the Chief of the Foreign Enforcement Branch in the Division of International Compliance Operations within the Office of Compliance, Center for Devices and Radiological Health (CDRH), FDA. The branch oversees the compliance efforts for medical device manufacturers outside the United States, and includes inspection review, recall classification, and administration of allegation of regulatory misconduct, as well as assisting the office, Center, and Agency for cross-cutting initiatives, for all device types. Daniel began his career at FDA as a compliance officer in, then was promoted to the branch chief of, the Vascular and Circulatory Support Branch in the Office of Compliance at CDRH. He is currently acting as the Branch Chief in the Gastroenterology Devices Branch of the Division of Reproductive, Gastro-Renal, and Urological Devices in ODE, working with epidemiologists and Medical Device Reporting analysts in OSB, to develop cross-cutting mechanisms to enhance patient outcomes through information sharing by developing “benefit-risk” based evaluation processes. Prior to working with FDA, Daniel Walter was a Validation Engineer, leading to becoming the Lead Quality Auditor and Director of Quality at DST Controls. Daniel’s experience includes facility, utility, equipment, and process validations for automated and non-automated systems, including for steam and compressed air distribution validations, cleaning validations, self-contained automated manufacturing lines for liquid and solid pharmaceutical manufacturers.
Staff Fellow, Division of International Compliance Operations, OC, CDRH, FDA
Marc-Henri Winter is Assessment Program Manager for the Medical Device Single Audit Program. He is a biomedical engineer and has been working since 1998 as assessor of medical devices and auditor of quality management systems according to international medical device regulations, including in particular the European and Canadian and US regulations. He joined the FDA in 2012 to support the development and the implementation of the Medical Device Single Audit Program.
Associate, Mintz Levin, LLP
Benjamin provides counsel on compliance and regulatory issues to clients in the pharmaceutical, medical device, and biotech industries. With a clear focus on FDA regulatory counseling, Benjamin advises a breadth of health care industry clients on the federal and state laws surrounding manufacturer product development and marketing. His practice also includes advising clients on research approval, sales, and negotiating contractual relationships. Benjamin has experience representing medical device companies in responding to significant unfavorable inspection observations, sometimes accompanied by a warning letter. He guides companies with compliance issues through the development stage of action plans and implementing corrective actions. In his practice, Benjamin participates in the coordination of diligence reviews of transactions involving large pharmaceutical and medical device manufacturers. He is well versed in the process of developing policy positions and submitting comments to the FDA, as well as analyzing and drafting 510(k) applications for submission to the FDA. Benjamin reviews and drafts clinical study agreements for clients, analyzing both clinical study and human factors protocols with respect to legal requirements. Benjamin has given numerous presentations on current health care industry topics, with titles such as Advertising and Promotion for Drugs, Devices and Biologics Using Social Media and Promotion of Investigational Drugs and Devices. He previously worked as a research chemist in the discovery group of a major research-based health care and pharmaceutical company. While in law school, he held the position of Executive Editor of the Cardozo Law Review.