Managing Director and Principal, Cerulean Associates LLC
John Avellanet is the author of Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine (2010, Logos Press), and founder of the FDA compliance consulting firm, Cerulean Associates LLC. Prior to founding Cerulean, John was a former Fortune 500 combination device C-level executive who created, developed, and ran his company’s compliance programs to achieve ISO, FDA, DEA, and HIPAA compliance. During his career, he had to defend decisions to inspectors, auditors, and litigators alike. John is also an expert member of the ISPE Data Integrity Working Group. He now brings that real-world experience and practical advice to his consulting clients, his articles, and his speeches.
Attorney at Law, Consultant, Backfield PLLC
With over 15 years of experience in the area of pharmaceutical regulatory law, including more than 10 years at the Food and Drug Administration, Katlin uses her extensive expertise to help companies navigate the pre- and post-approval stages of drug development. Katlin served as Associate Chief Counsel for Drugs with the Office of Chief Counsel at FDA for nine years. She was a regulatory counsel in the Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research at FDA from 2006 to 2008. Prior to joining FDA, Katlin was an associate at Hogan Lovells, LLP, and a law clerk for the Honorable Douglas P. Woodlock of the U.S. District Court for the District of Massachusetts. She graduated cum laude from Georgetown University Law Center in 2001 and received her undergraduate degree from Davidson College. Katlin serves on the planning committee for the Food and Drug Law Institute's Advertising and Promotion Conference to be held in September 2017 and is a member of FDLI's Academic Programs Committee. She is based in Washington, D.C.
Carol Bennett, J.D. (Invited)
Deputy Director, Office of Regulatory Policy, CDER, FDA
Partner, King & Spalding
Mark Brown is nationally recognized in Food & Drug Administration regulatory matters, civil litigation, criminal investigations and prosecutions, compliance matters and comprehensive risk assessments. Mark advises pharmaceutical, medical device and biotech companies, and pharmacies, on a broad range of FDA requirements and FDA regulatory issues that arise in products liability litigation and other disputes. A former Associate Chief Counsel for FDA, Mark is the Chair of the FDA and Life Sciences practice.
Principal and General Manager, DL Chesney Consulting LLC
David Chesney is the Principal and General Manager of DL Chesney Consulting. He provides consulting services to a worldwide client base, including GMP, GCP, inspectional readiness and post-inspection remediation assistance. Previously he served 23 years with the FDA, where he advanced from Investigator to Supervisory Investigator and Director, Investigations Branch, working in the Boston, Seattle and Philadelphia District Offices. In 1991, he was appointed the District Director, FDA San Francisco District Office, where he served until joining PAREXEL in 1995. Since joining PAREXEL, Mr. Chesney has provided compliance consulting and training services to clients worldwide. He is active in PDA, where he serves as an instructor for the PDA Training and Research Institute, and the Food and Drug Law Institute where he serves on the Drugs and Biologics Committee and as an instructor for FDLI’s Introduction to Drug Law course. Mr. Chesney has a bachelor's degree plus postgraduate credits in biology from California State University, Northridge and San Diego, and received a Certificate in Health Care Compliance from Seton Hall University School of Law.
Dara Corrigan, J.D. (Invited)
Associate Commissioner, Office of Global Regulatory Operations and Policy, OC, FDA
Dara Corrigan, J.D., is the Acting Deputy Commissioner for Global Regulatory Operations and Policy (GO), the Directorate comprising the 5,000-member workforce of the Office of Regulatory Affairs and the Office of International Programs. Ms. Corrigan provides executive oversight, strategic leadership, and policy direction to FDA’s domestic and international product quality and safety efforts, including global data-sharing, development and harmonization of standards, field operations, compliance, and enforcement activities. Ms. Corrigan joined FDA in 2010, serving as Associate Commissioner for Regulatory Affairs and then as Director of FDA’s Europe Office in Brussels, Belgium. She served as FDA's chief negotiator for the United States/European Union Mutual Recognition Agreement - a collaboration with the European Union to ensure that the public has access to quality pharmaceuticals.
Executive Vice President of RA/QA, Cynosure
Connie has more than 25 years of experience in medical devices including class III sterile implantable devices, radiation oncology and lasers. Currently she is the senior VP of Regulatory Affairs with Cynosure. Prior to this role, she was the VP of Regulatory Affairs and Corporate Compliance with Cutera, Inc. Previously Connie was the VP of RA and QA at Xoft, Inc. and VP of RA and QA at Lumenis. She has extensive international submission experience, including Japan and China. Connie regularly teaches international regulatory and complaint handling classes for ASQ. Connie’s proudest personal accomplishment is that she is a certified scuba instructor and certified handicapped scuba instructor who volunteers to teach handicapped vets how to scuba dive through the Wounded Warrior program.
Senior Partner, Director Inspection Readiness Services, BioTeknica
Julie Larsen is principal and director, Inspection Readiness Services, at BioTeknica, Inc. A certified quality manager, Julie has more than 20 years of experience with quality assurance and compliance in manufacturing and corporate roles in medical device and pharmaceutical industries, including 17 years of leadership experience in quality operations and compliance at Abbott. She has extensive experience with strategy, coordination, and management of FDA inspections, remediation of quality systems for compliance improvement as well as successfully addressing consent decrees, warning letters and FDA Form 483 responses. Julie has helped multiple companies prepare for and manage FDA inspections in both the US and in Europe with successful outcomes.
Associate Commissioner, OMPTO, ORA, FDA
Ms. Morrison is the assistant commissioner for medical products and tobacco operations (ACMPTO) in the Office of Regulatory Affairs (ORA) at the FDA, leading a team that serves as focal point for coordination and management of ORA’s medical product and tobacco field activities. Ms. Morrison received her B.A. in Biology from Regis College, and completed graduate work in Environmental Health at New York University; she has completed courses in Crisis Management Leadership and National Preparedness Leadership at Harvard University Kennedy School of Government, and also attained a graduate certificate in Terrorism Studies from the University of St. Andrews. In 2002, FDA named Ms. Morrison the Director of Emergency Operations, Office of Crisis Management, where she directed and coordinated FDA’s emergency preparedness and response activities with federal, state, local, and international agencies, becoming the first Director of the Office of Crisis Management in 2003. She returned to ORA first as acting in 2012 and then officially in 2013, as the Assistant Commissioner for Operations. In 2017, she took on the role of Assistant Commissioner for Medical Products and Tobacco Operations for ORA, providing leadership for and management of the program directors for biological products, bioresearch monitoring, medical devices and radiological health, and pharmaceutical quality operations.
Director, Office of Compliance, CDRH, FDA
Robin Newman joined FDA in February 2016 as Director, Office of Compliance at CDRH. She has 20+ years of senior level clinical/regulatory and compliance management in new product research and development. Ms. Newman’s experience includes senior level consulting for regulatory strategy, clinical trial design and execution, standards and SOP development, quality system management and compliance, clinical & medical writing, customer/public interface and education, and management of Data Safety Monitoring Boards and Clinical Event Adjudication Committees. Most recently, Ms. Newman served as the Vice President of Quality Management for Siemens Healthcare Diagnostics, where she managed a multidisciplinary quality management team and functioned as the primary representative for AdvaMedDx and the Diagnostic Tests Working Group. She holds a B.S. and M.S. in Nursing from the University of Texas, an Ed.D. from The George Washington University’s Executive Leadership Program, and holds certifications as a Pediatric Nurse Practitioner, in regulatory affairs (RAPS), and as a CCRA (ACRP).
Lead Quality Systems and Compliance Consultant, King and Spalding LLP
Steve 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. He provides strategic advice, insight and guidance to the medical device, pharmaceutical, biologics and food industries to ensure FDA compliance. Steve 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 ORA, including the Office of Regional Operations, Office of Enforcement and Office of Criminal Investigations. Additionally, Steve assisted in the day-to-day management of FDA’s nearly 3,400 field staff responsible for investigative and laboratory operations. While at ORA, Steve served as the principle liaison to the CDRH, and was a member of the 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. Steve currently participates as a member of the Medical Devices Committee at FDLI and as a member of the editorial review boards for FDAnews’ GMP publications.
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 Master’s 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.
Executive Vice President, Regulatory Compliance, Greenleaf; former Director of the Office of Compliance, CDER, FDA
With more than 25 years of experience as an expert in compliance issues – including more than 20 years in leadership positions in the government – Cynthia adds to Greenleaf Health’s prestige as Executive Vice President, Regulatory Compliance. Cynthia was formerly Director of the Office of Compliance for FDA’s CDER, where she led a staff of more than 300 doctors, scientists, manufacturing experts, pharmacologists, attorneys, and administrative staff. During her time at FDA, she spearheaded efforts to protect the American public from unsafe and ineffective drug products by ensuring that companies comply with federal standards for quality and safety. Among her many duties, Cynthia advised the FDA Commissioner, the CDER Director, and other senior FDA officials on significant enforcement issues. Before joining FDA in 2014, Cynthia spent more than two decades at the DOJ, where she specialized in compliance and enforcement issues. Her most recent position at DOJ was as Deputy Inspector General and Acting Inspector General, where she led a nationwide staff in investigating allegations of corruption and misconduct concerning DOJ’s employees and in conducting independent audits of the Department’s operations and programs. She communicated significant findings from the investigations and reviews to the Attorney General and to Congress. Cynthia’s other positions at DOJ also provided her with an extensive background in criminal and civil enforcement work. They included Counselor to the Inspector General, Deputy Chief of the Sex Offense and Domestic Violence Section in the U. S. Attorney’s Office for the District of Columbia, Assistant U. S. Attorney, and Trial Attorney in the Civil Fraud Section of the Civil Division. Previously, Cynthia clerked for a federal judge on the Ninth Circuit and worked as a television reporter in New Mexico and Texas. Cynthia earned a B.A., with distinction, from the University of New Mexico and a J.D., with honors, from the University of Texas School of Law.
Fellow, Regulatory Compliance Associates, Inc.
Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. As a pharmaceutical quality assurance thought leader with 35 years’ experience, Sue has held leadership roles in industry at Allergy Laboratories, Inc., OsoBio Pharmaceuticals, LLC, Searle, Abbott and Hospira. She is a member of the PDA Board of Directors, and has served as PDA/FDA Joint Regulatory Affairs Conference Chair, conference presenter, and chair of the PDA’s Regulatory Affairs/Quality Advisory Board. Sue was awarded PDA’s Distinguished Service Award in 2008.
Douglas Stearns (Invited)
Director, Office of Enforcement and Import Operations, ORA, FDA
Douglas Stearns is currently the director of the Office of Enforcement and Import Operations. The office is comprised of the Division of Import Operations, the Division of Enforcement, and the Division of Compliance Systems, which are the ORA headquarters units responsible for coordinating activities related to imports, compliance, recalls, and data systems. Douglas began this position in December 2013 after spending almost four years as the assistant director and then the deputy director of the Office of Compliance within FDA’s Center for Drug Evaluation and Research. Prior to joining CDER, Douglas was the director of the Division of Compliance Policy in the Office of Enforcement for almost two years. Douglas received his undergraduate degree from Brown University in 1987. He received his law degree in 1991 from Cornell Law School. Immediately before joining FDA, He worked as a trial attorney in the U.S. Department of Justice’s Office of Consumer Litigation for over fifteen years. In the course of his work at the Department of Justice, Douglas litigated numerous civil and criminal cases referred by FDA and other consumer protection agencies.
President, IntegRx, Inc.; former FDA Chemist, ACNA and Investigator, Atlanta District Office Drug Cadre
Vicky Stoakes has more than 18 years combined consulting, FDA, and industry experience, including hands-on execution of laboratory responsibilities. Vicky has been a consultant to the FDA-regulated industry since 2002. In this capacity, she has performed cGMP and mock pre-approval inspections of international and domestic firms and identified critical and major deficiencies. She has assisted in guiding and developing corrective action plans, validation plans, formal responses and correspondence with the FDA. Previously, Vicky served as a chemist and as an investigator for the FDA’s Atlanta District Drug Cadre. In both roles, she conducted numerous cGMP and NDA/ANDA pre-approval inspections at major pharmaceutical facilities, including compliance audits of active pharmaceutical ingredients and major dosage forms. As the Acting NDA/ANDA Pre-Approval Manager for the Atlanta District Office, she facilitated high priority pre-approval assignments, performed technical review of applications and provided assessment of pending NDAs/ANDAs. She trained other FDA investigators, analysts, and regional employees in the procedures and methods of evaluating compliance during drug inspections to ensure consistency with agency policy. Vicky began her career in the pharmaceutical industry with Merck & Co., where she provided technical support for the production of APIs in accordance with cGMP requirements.
Ibim Tariah, Ph.D.
Technical Director, BSI Americas Inc.
Dr. Ibim Tariah is the Technical Director for BSI Healthcare with more than 23 years of experience in the medical device industry. In the last 14 years, since coming to BSI, Dr. Tariah has been providing regulatory expertise in the area of long term implantable devices for clients needing technical documentation assessment and reviews in compliance with the European Medical Device Directive (MDD). He also acts as a liaison with regulatory authorities including MHRA, EMA, Medical Products Agency (Sweden), FDA, Health Canada and Therapeutic Goods Administration (TGA).
Vice President Manufacturing Quality, Patient Monitoring and Recovery, MITG, Medtronic
Karl Vahey is currently the Vice President Manufacturing Quality with Medtronic. Karl has 25 years of experience in the medical device industry and has worked in manufacturing, quality assurance, regulatory affairs and quality systems compliance. His current responsibilities include overseeing quality operations and quality compliance for 16 manufacturing facilities in North and South America and Europe. Prior to this Karl was Senior Director of Regulatory Compliance, Covidien. This role included the following responsibilities: quality compliance activities such as conducting audits, development of best practices and providing general support as appropriate to Covidien facilities (manufacturing, distribution centers and technical service centers) and third-party suppliers in EMEA, Latin America and Asia Pacific. Karl was also heavily involved in the development of corporate quality system training programs such as process validation, CAPA, internal audits, change management and the implementation of these corporate training programs to all international sites.