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
Acting Director, Office of Compliance, CDRH, FDA
Capt. Sean Boyd is an active duty commissioned officer in the United States Public Health Service (USPHS). He currently serves as the Acting Director of the Office of Compliance in FDA’s CDRH. In this capacity he is responsible for managing the Center’s quality, regulatory compliance, and enforcement programs for the medical device industry. Previously, CAPT Boyd served as the Deputy Director of the Division of Radiological Health in the Office of In Vitro Diagnostics and Radiological Health at CDRH. He began his career in 1994 as an engineering analyst in FDA’s Winchester Engineering and Analytical Center, joining CDRH in 1999 as a compliance officer. CAPT Boyd progressed through several branch and division management positions within the Center, and has been responsible for a variety of premarket, compliance, surveillance and outreach programs over the course of his career. He received his undergraduate degree in Biomedical Engineering from Boston University and his Master’s Degree in Public Health and Preventive Medicine from the Uniformed Services University of the Health Sciences. CAPT Boyd is also Team Commander for one of two Washington DC-based medical response teams (PHS-1 Rapid Deployment Force); and deployed in response to several disasters and crises, both domestically and abroad. This experience includes the USPHS Commissioned Corps Ebola Response in 2015, where he served as Deputy Officer in Charge of the Monrovia Medical Unit in Margibi County, Liberia. Past deployments also include serving as Team Commander at Brookdale Hospital (Brooklyn, NY) in 2012 following Hurricane Sandy, Lead Safety Officer at Federal Medical Center (College Station, TX) in 2008 following Hurricane Ike, and Corps Liaison to the HHS Secretary’s Command Center (Washington, DC) in 2005 following Hurricane Katrina.
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.
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.
Counsel, King & Spalding; former Associate Chief Counsel for Enforcement in FDA’s Office of Chief Counsel
Pete Leininger is a member of the firm’s FDA & Life Sciences Practice in Washington, D.C. He represents medical device, pharmaceutical and biotech companies in FDA regulatory and enforcement matters, including civil and criminal government investigations. From 2012-2017, Pete served as an Associate Chief Counsel for Enforcement in FDA’s Office of Chief Counsel. Pete’s enforcement practice at FDA covered the range of FDA-regulated products, often focusing on product quality, GMP/QSR compliance, MDR reporting, and promotional activity. He frequently handled criminal investigations arising out of qui tam lawsuits filed against drug and medical device manufacturers under the False Claims Act. During the course of his employment at FDA, he was admitted to serve as a Special Assistant United States Attorney (SAUSA) in several United States Attorney’s Offices. As a SAUSA, Pete helped lead grand jury investigations and criminal prosecutions involving violations of the Food, Drug, and Cosmetic Act, as well as related Title 18 criminal offenses, including health care fraud and false statements. In 2016, Pete received an Outstanding Service award from FDA’s Office of Commissioner for his representation of the agency in enforcement litigation. He also received two special recognition awards from the Los Angeles Field Office of FDA’s Office of Criminal Investigations. The first was awarded for his work as a SAUSA at trial in United States v. Kaplan. The second was awarded in 2017 for his overall service to the agency. Prior to joining FDA, Pete was an associate at an international law firm, where he specialized in government investigations and False Claims Act litigation in the health care and life sciences industries.
Associate Director for Global Regulatory Policy, Office of Global Regulatory Operations and Policy, OC, FDA
Under the guidance of the Office of the Commissioner, Dr. Mehta serves in a key capacity to manage and execute the Mutual Reliance Initiative, a priority alliance for FDA senior leadership. In his 10 year career with the FDA he also served as the Acting Branch Chief of the Office of Product Quality and Senior Advisor for Global Policy.
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.
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.
Principal/Project Manager/Senior Quality Engineer, BioTeknica, Inc.
Co-Founder Braulio Ortiz brings more than twenty years of experience in quality assurance, engineering, and manufacturing in the biomedical, pharmaceutical, and medical device industries to BioTeknica. He has extensive experience in design, installation, and continuous improvement of 21 CFR and ISO 9001 compliant quality systems as well as successful outcomes with FDA inspections, Consent Decree and Warning Letter responses. He also has experience developing technical organizations, as well as designing and leading strategic business initiatives. Braulio’s expertise includes quality systems improvement strategies, Six Sigma, Business Process Re-Engineering, facilities commissioning, validation, and cost reduction initiatives.
Marla A. Phillips, Ph.D.
Director, Xavier Health, Xavier University; former Head of Quality at Merck’s North Carolina facility
Dr. Marla A. Phillips joined Xavier University in 2008 as the Director of Xavier Health, where she creates and leads initiatives for the Food, Drug, and Medical Device Industries. These initiatives bring global regulators and industry together in an effort to collaboratively address the most pressing challenges faced by those industries. Phillips aligns the mission of Xavier Health with the Strategic Priorities of the FDA. Phillips is the founder and co-chair of the FDA/Xavier University Medical Device Conference; founder and co-chair of the FDA/Xavier University PharmaLink Conference; founder and chair of the Integrity of Supply Initiative for the food, drug and device industries; and founder and chair of the Board of Directors for the QA/RA Institute of Xavier University. Additionally, Phillips serves as a consultant and expert witness to the pharmaceutical industry. Phillips started in the industry in 1996 when she was employed by Merck & Co., where she quickly took on positions of increasing responsibility, culminating in the position of Head of Quality Operations at the Merck North Carolina facility in 2000.
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.
Lenita Y. Sims Spears
Senior Quality Consultant/Senior Regulatory and Compliance Counsel, BioTeknica
Lenita is an accomplished regulatory attorney, adjunct law professor and RA/QA Compliance professional with over 25 years domestic and international experience in the highly regulated medical device and pharmaceutical industry. After a long and distinguished career in leadership with several Fortune 500 companies, in 2009 she started her own consulting firm, LYS Compliance Consulting where her focus was helping small medical device companies navigate the often cumbersome web of US FDA regulations and International standards. In June of 2014, Lenita joined the medical device consulting firm of BioTeknica, Inc. in the role of Senior Quality Systems Consultant & Senior Regulatory Counsel where she continues to provide strategic support and information to healthcare companies across the globe. Lenita is an active member in varied professional associations, including membership in ABA, Illinois, Cook and Lake County Bar Associations, American Society for Quality (ASQ), Regulatory Affairs Professional Society (RAPs). She serves as an active member on the Board of Directors for several non-profit organizations including the State of Illinois NAACP Parliamentarian, Chair of the NAACP of Lake County legal redress committee, Fuller Center for Housing Lake County, the Lake County Branch of the Salvation Army, State of Illinois Legal Counsel Chair for Zeta Phi Beta Sorority, Inc., and Legal Advisory Chair for the Chocolate Chips Association, a mentorship organization encouraging academic enrichment in STEM based programs for minority girls ages 7 to 11. Her philanthropy also includes volunteer work at Staben House, temporary residential facility for women in transition and their children, and volunteer for Prairie State Legal services. Lenita holds a Bachelor’s degree in Biology from Roosevelt University in Chicago, a Master’s Degree in Human Development and Counseling from the University of Illinois, and a Juris Doctorate from the John Marshall Law School, in Chicago. She and her husband of 32 years live in Mundelein, IL and are recent empty-nesters and the continuing proud parents of three wonderful children.
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, Cardinal Health
Karl is currently Vice President Manufacturing Quality with Cardinal Health and have 27 years of experience in the medical device industry working in Manufacturing, Quality Assurance, Regulatory Affairs and Quality Systems Compliance. His current responsibilities include overseeing Quality Operations for manufacturing facilities globally in USA, Latin America , Asia and Europe. Prior to this he was Vice President Manufacturing Quality with Medtronic with responsibility for Manufacturing Quality operations globally and before that held the position of 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.