The FDA/Xavier MedCon speakers are hand-selected by the MedCon Strategic Committee to deliver purpose-driven content that dives below the surface, challenge status quo, engage attendees in collaborative dialog, and provide practical information that can be implemented. Our speakers are thought leaders who are sure to facilitate insightful discussion.
Senior Director, Regulatory Strategy and Advocacy
Philippe is a Pharmacist, Ph.D. Since joining Abbott in 1994, he worked as International Regulatory Compliance for Abbott Vascular and is now responsible for Regulatory Strategy and Advocacy for Abbott Laboratories. He represents European Industry in various European Commission expert groups and served until end 2012 as secretary of the Global Harmonization Task Force Study group 2 dealing with adverse events reporting.
He actively participates as trainer in programs organized by Regulatory Authorities in various geographies, such as Europe, Colombia, Brazil, China, India, Mexico, United States and serves since 2015 as an advisor to the Asian Harmonization Working Party Technical Committee. Philippe is Chairman of the Post Market Surveillance, and the Notified Body Working Groups of the European medical device manufacturers’ trade association Medtech Europe. He also serves as Co-Chair of the European Advisory Committee and is a member of the board nominating committee of the Regulatory Affairs Professional Society (RAPS). Philippe received the “Global Leadership Award” from RAPS in 2010, has been elected “RAPS Fellow” in 2012.
Cincinnati District Director
Steven Barber has been selected to the position of District Director for the Cincinnati District. During his 25 year career with FDA, Steve has worked in six different field offices (Chicago, Kansas City, Florida, San Juan, Baltimore, and Detroit). Within these districts, Steve has served in the laboratory as an analyst conducting food and drug analyses, as an investigator conducting medical device and drug inspections, both domestically and internationally, and as a compliance officer. Steven has served as the Director of the Compliance Branch in FDA’s Detroit District Office since 2008.
Director of Compliance, Florida District
Blake has been with the Food and Drug Administration since 1989. He was an Investigator for 12 years which included conducting foreign inspections. He accepted a Supervisory Investigator position in 2001. Following his participation in the FDA Leadership Program in 2005 and 2006 he became an Operations Director and worked directly with the Associate Commissioner for Regulatory Affairs and other agency leaders involved in ORA strategic planning, budgeting, and organizational initiatives. Blake became the Director of Compliance for Los Angeles District in 2009 and assumed the Director of Compliance position in Florida District in 2014.
He graduated from Harding University with a bachelor's degree in Biology, Arkansas State University with a master’s of science degree in biology, and completed a Senior Executive Development program at George Washington University.
Director, Regulatory Policy and Technology Corporate Regulatory Affairs
Steve has spent over 25 years in industry, with 20+ years of increasing responsibility for pre- and post -market regulatory support of biologics, devices, drugs, and combination products. His formal regulatory experience began in 1992, when he joined Allergan Pharmaceuticals as Director, Worldwide Regulatory, and Responsible Head for the company’s Botox biologic.
In 1994 he joined Baxter’s Fenwal Division as Vice President, Regulatory Affairs, and for the next 10 years he led a global regulatory team with responsibility for the division’s 510(k), PMA, and NDA products used in blood component processing and delivery. While at Baxter Steve also gained extensive experience with CE marking of medical devices in the EU, including Class III devices incorporating medicinal products. In 2005 Steve joined Becton Dickinson and Company (BD) as Director of Regulatory Affairs in BD’s Corporate research center, BD Technologies, where his responsibilities included providing support for technology development efforts in areas including diagnostics, cell and tissue technologies, and advanced diabetes care. In 2011 he also took on responsibility for the Women’s Health and Cancer Regulatory team in BD’s Diagnostics Systems business. In August 2014 he transitioned to a new Corporate Regulatory Affairs role as Director, Regulatory Policy, Technology, and Communications for BD. He is active in a number of medical device and IVD policy issues on behalf of BD through his involvement in AdvaMed and several industry coalitions.
Steve obtained his Ph.D. in immunology from Kansas State University and has an MBA from the University of St. Thomas, St. Paul, Minnesota.
Global Quality Leader – Drug Delivery System Development
Francis Blacha is currently Global Quality Leader, Drug Delivery System Development, Device Manufacturing and Diagnostics for Eli Lilly and Company. Previous to joining Lilly, Francis held various leadership positions in Quality at Pfizer and Glaxo Inc. Francis has over 25+ years of quality assurance/quality control experience in pharmaceuticals and medical devices. He has extensive experience in guiding project teams in all aspects of risk management and the application of design control requirements throughout the product lifecycle for combination products, diagnostics and medical devices. In addition to frequently presenting at industry forums on the topic of risk management, Francis currently serves on the strategic committee for MedCon, an annual medical device conference co-sponsored by FDA and Xavier University and is a member of the advisory board for Xavier’s QARAInstitute. Francis received his B.A. in chemistry from Catawba College and his M.S. in chemistry from North Carolina State University.
Executive Director & Partner
Gert is an expert in European regulations based on 15 years hands-on working in the field, as auditor, product reviewer, regulatory specialist, and Head of notified body. He has been leading the Notified Bodies in Brussels for many years, and has strongly supported the regulatory debate with the EU Commission, EU Parliament and the EU Council of Ministers. He combines strong experience in quality, compliance and regulations with a pragmatic, result driven approach at both operational and strategic level.
From his Ph.D. in biomaterial sciences, and postdocs in controlled release of drugs and gene therapy, he has dealt as technical reviewer with a large range of devices mostly in the non-active device area. For his contributions to the regulatory profession over the last 15 years he has been awarded as Fellow of RAPS.
Gina has been with the Food and Drug Administration since 1990. Prior to taking the compliance officer position, she was the Medical Device Specialist in the Cincinnati District Office for seven years. She is still a medical device performance auditor; and the majority of her case work involves medical device firms. She graduated from Thomas More College with a bachelor’s degree in biology and an associate degree in chemistry.
Director, Regulatory Affairs
Bill Brodbeck is Director, Regulatory Affairs at STERIS Corporation in Mentor, Ohio. Bill shares the responsibility for FDA submissions and interactions while helping to maintain compliance with FDA requirements, guidance and processes. He is the Regulatory lead for sterility assurance products (SAPs) including biological indicators & chemical indicators as well as Vaporized Hydrogen Peroxide (VHP) Low Temperature Sterilization Systems.
Bill received his Ph.D. in the Cellular and Molecular Basis of Disease from Case Western Reserve University and his B.S. in Biology from Wilkes University. He is an active member of the Association for the Advancement of Medical Instrumentation (AAMI) sterilizations standards committee.
Senior Compliance Expert, Medical Devices
IHL Consulting Group
Karen retired after 30 years with FDA, the last 15 of which she was a Medical Device National Expert. Karen served as FDA Certified Device Investigator and a Medical Device Performance Auditor. She conducted cGMP and Pre-Market inspections both domestically and internationally involving complex devices, sterile devices, tissue devices, diagnostics, and radiological equipment. She served as a principal FDA instructor in the agency for FDA Quality Systems training courses and Industrial Sterilization. She was an instrumental FDA representative on the Global Harmonization Task Force (GHTF), Study Group 4 on Auditing. She received special agency recognition at the highest levels including the Commissioner’s Special Citations, Commendable Service Awards, and Outstanding Service Awards. Karen holds a Bachelor of Science degree from the University of Montevallo and a Master of Science degree from Auburn University.
Vice President, Quality and Regulatory Affairs
IBM Watson Health
John joined IBM in May of 2016 and is responsible for ensuring Watson Health’s portfolio complies with all relevant lifescience related regulations. Prior to joining Watson Health, John was with Boston Scientific for nine years and had a number of positions there including the head of International Quality, Distribution and Supply Chain and management board level positions for their Endoscopy and Urology and Women’s Health. Prior to Boston Scientific, John worked for Johnson & Johnson and held quality related positions in their device, diagnostic, and pharmaceutical sectors. John has over 20 years of experience with FDA regulated industries and has special expertise in Design Control, Software Quality, and Quality Systems.
Investigator, Medical Device Specialist
Ben has been with the FDA since 2000 conducting both domestic and foreign inspections of medical device manufacturers. Ben has conducted numerous industry presentations and has worked with other government agencies such as FBI, US attorney’s office and DOJ. Prior to joining FDA, he held positions of certified Senior Clinical Research Coordinator, CCRC, at Case Western Reserve University/ University Hospitals, Andrologist / Embryologist at Mt. Sinai Hospital and has conducted NIH sponsored research at the Cleveland Clinic Foundation. Ben is a graduate of Miami University, Oxford, OH.
Assistant Professor and Director, Regulatory Affairs
George Washington University
Dr. Daniela Drago is Assistant Professor and Director of Regulatory Affairs Programs at The George Washington University’s School of Medicine and Health Sciences. Before joining academia, she held senior positions in the pharmaceutical and medical device industry. She worked in global regulatory and medical affairs roles at F. Hoffman-La Roche/Genentech, Vifor Pharma, Reckitt Benckiser, and Bausch & Lomb. Daniela contributed to more than 100 global regulatory submissions. Her current research interests focus on optimizing the development of FDA-regulated products and advancing regulatory science. Daniela received her Ph.D. in chemistry from the Swiss Federal Institute of Technology (ETH Zurich).
President and Principal Regulatory Consultant
Clinical Research Consultants, Inc.
Barbara Fant, Pharm.D. is the President and Principal Regulatory Consultant of Clinical Research Consultants, Inc. (CRC), and has 30 years of experience in pharmaceutical and medical device research and development.
Dr. Fant is nationally and internationally recognized as an expert provider of FDA regulatory and clinical services for the development and approval of corneal, refractive, intraocular, and other ophthalmic medical devices. She has over 20 years of experience in working with FDA in the management of ophthalmic clinical studies and regulatory submissions for ophthalmic, orthopedic, and diagnostic devices. Dr. Fant has successfully filed over a hundred IDE’s, pre-IDE’s, 510(k)’s, and PMA’s with the FDA to bring investigational products to the marketplace. Dr. Fant has also served as the ophthalmic technical reviewer for one of the most highly respected notified bodies in Europe for awarding CE mark certification.
Dr. Fant is an active member of the ophthalmic community. She serves on several ANSI subcommittees for the development of ANSI ophthalmic standards, is a peer reviewer for several ophthalmic journals, and is a member of numerous national and international ophthalmic professional organizations.
Dr. Fant frequently trains established companies in the process of medical device development, FDA regulations, and Good Clinical Practices; and provides customized in-house training on various aspects of regulatory and clinical affairs for several leading educational providers.
Dr. Fant holds a B.S. in pharmacy from Ohio Northern University and a Doctor of Pharmacy degree from the University of Cincinnati.
Director, Regulatory Policy Innovation
Johnson & Johnson Medical Devices
Dennis Hahn, RAC is currently the Director, Regulatory Policy Innovation, Johnson & Johnson Medical Devices. He is responsible for ensuring global regulatory policies are appropriately interpreted, effectively communicated and efficiently implemented in the ETHICON surgical device businesses. He has worked in the medical device industry for over 30 years, the past 23 in Regulatory Affairs. Mr. Hahn has broad experience with in the registration of medical devices globally, with numerous product approvals to his credit, in the US, Japan, China, Brazil, European Union and other regulated markets around the world. He received his Bachelor of Engineering degree in chemical engineering from the Stevens Institute of Technology.
Senior Vice President, Compliance
Michael Mascali is Senior Vice President, Compliance. Mr. Mascali joined VWR as part of its acquisition of AMRESCO in February 2011. Mr. Mascali first joined AMRESCO as Vice President of Regulatory Affairs in May 2006. In December 2012, Mr. Mascali was promoted to President of AMRESCO, and subsequently accepted responsibility for additional VWR acquisitions including United Biochemicals Inc. in Sanborn, New York, and National Biochemicals in Aurora, Ohio.
In June 2015, Mr. Mascali was promoted to Senior Vice President, Compliance, and he has maintained this role, as well as his role with AMRESCO, since that time. Prior to joining AMRESCO, Mr. Mascali served as Vice President of Pharmacy Operations for Marc Glassman, Inc., Senior Vice President of Operations for NEO-PET, LLC, and most notably, Senior Vice President for NCS Healthcare. Mr. Mascali is a Pharmacist and Fellow of the American Society of Consultant Pharmacists.
Global MDSAP Manager
BSI Group America
Patricia L. Murphy is the Global MDSAP Manager, at BSI, with responsibility for all aspects of the Medical Device Single Audit Program. Patty will be responsible for maintaining BSI’s leadership role as the MDSAP program moves from the Pilot Phase into the Operational Phase. This will be accomplished by continuing to develop the competence of our assessment staff to meet the needs of our customers. Patty has worked in Medical Devices and Quality Assurance for over 25 years. Patty’s most recent role has been as VP of Quality Assurance and Regulatory Affairs for a US based Medical device manufacturer. Prior to that, she worked as Director of Quality Assurance, Principal Consultant and Certification Manager for a EU-based Certification Body.
Director, Office of Compliance
FDA – CDRH
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 in as a CCRA (ACRP).
Lead Quality System & Compliance Consultant
King & Spalding
Mr. Niedelman retired from the Food and Drug Administration 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. 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 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 specializes in regulatory, enforcement and policy matters involving industries regulated by the U.S. Food and Drug Administration. 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.
University of Cincinnati, College of Law
Professor O’Reilly has been involved with FDA issues since 1974. He authored the standard reference encyclopedia on FDA for westgroup.com, which the U.S. Supreme Court quoted with the words, “The experts have written…”. He chairs the FDA committee of the American Bar Assn., is on the editorial board of the Food & Drug Law Journal, formerly chaired the programs committee of the Food & Drug Law Institute, and was keynote speaker at the FDA’s midwest celebration of its 100th anniversary in 2006. Before his academic career, he was principal FDA legal adviser for Procter & Gamble, and is the last active member of the team that negotiated the terms of the 1976 medical device amendments. He has published 51 texts and 215 articles since 1977.
Associate Center Director for Digital Health
Bakul Patel is a digital-health visionary and entrepreneurial leader focused on creating, shaping, and implementing national and international public health strategies. He has over 28 years of experience in leadership business development, marketing, product management, assessing long and short term needs, establishing objectives, improving organizational performance, and resource management.
Patel is an excellent collaborator, experienced in building effective cross functional teams by establishing and maintaining working relationships with diverse set of internal and external stakeholders. He has strong management, technical and regulatory skills in identifying, analyzing, managing, and solving highly complex issues, policies, procedures, federal regulations, and legislative matters in relation to Food Drug and Cosmetic Act. Patel has a detailed understanding of the regulatory infrastructure needed to balance regulatory requirements with national needs while developing policies and regulations.
He has expertise in medical device regulations, product development processes, software engineering, embedded systems, wireless communication systems, and robotics and control systems. Patel holds a master's degree in electronics engineering, M.B.A. in international business, Six Sigma, and Black-belt certified.
Director, Xavier Health
Dr. Marla A. Phillips joined Xavier University in 2008 as the Director of Xavier Health, where she leads initiatives with FDA officials and Pharmaceutical and Medical Device professionals. Marla began working in the pharmaceutical industry for Merck in 1996 where she took on roles of increasing responsibility, culminating in position of Head of Quality Operations at the Merck North Carolina facility. She holds a B.S. in chemistry from Xavier University, and a Ph.D. in organic chemistry from the University of North Carolina – Chapel Hill.
Phillips Consulting Group, LLC
Philip Phillips is President of Phillips Consulting Group, LLC. He has 32 years of experience in FDA regulation of medical devices, having focused on the development and implementation of numerous regulatory strategies regarding the design, manufacture and marketing of medical devices in the US. Mr. Phillips brings an in-depth knowledge of a wide range of regulatory matters, including FDA jurisdiction, device classification, clinical trials, and product labeling, including promotion and advertising. During his 24-year FDA tenure, Mr. Phillips streamlined the medical device review processes and launched numerous agency initiatives aimed at enhancing public health while lessening regulatory burden. In addition to serving as the Office of Device Evaluation’s Deputy Director for Science and Regulatory Policy for 12 years, he served as Director of Program Operations, Interim Director for the Division of General and Restorative Devices, Deputy Director for the Division of Ophthalmic Devices and the Chief of the Surgical and Diagnostics Devices Branch in DOD. Mr. Phillips holds a BS in Microbiology from the University of Maryland and a MBA from the George Washington University.
National Device Expert
Phillip Pontikos is a Medical Device National Expert working for the Office of Regulatory Affairs (ORA) of the Food and Drug Administration. Mr. Pontikos joined FDA in 1994 as an Investigator in the Brunswick, Ohio Resident Post of Cincinnati District. In 2000, Mr. Pontikos moved to the Columbus, Ohio, where he currently resides.
Mr. Pontikos previously held the position of Cincinnati District Medical Device Specialist until January 2010 when he became the Medical Device National Expert. Mr. Pontikos is responsible for conducting medical device inspections domestically and abroad. He is a Level II Certified Medical Device Investigator and Medical Device Performance Auditor. Mr. Pontikos has assisted in the development and actively participates as a trainer for numerous FDA courses including Computer Aided Inspections, Basic Medical Device, Industrial Sterilization for Drugs/Devices, and Process Validation. He has also served as a mentor and acting Supervisor. Mr. Pontikos has also given numerous lectures at various medical device and pharmaceutical conferences.
Mr. Pontikos received a bachelor’s degree in physics with a concentration in computer hardware systems from Kent State University.
Executive Vice President, Regulatory and Quality Systems
Meridian Bioscience, Inc.
Susan has over 25 years of experience in the in vitro diagnostic device (IVDD) industry. Since joining Meridian Bioscience, she has been responsible for the quality oversight of Meridian’s diagnostic and Life Science affiliates in the US and Europe. She has extensive experience in due diligence assessments, design controls, quality auditing, process development, regulatory submissions and product training for both the IVDD and blood products industries. Susan earned her Bachelor of Science Degree from Arizona State University and her Master of Science Degree from the University of Cincinnati. She has authored numerous journal articles on blood group serology and has served as an editor for several reference books.
Executive Vice President, Medical Devices & Combination Products (Vice President Regulatory Affairs, MDMA)
Heather Rosecrans brings more than 30 years of public health and medical device experience to Greenleaf Health Inc. Prior to joining Greenleaf, Rosecrans served as Director of the 510(k) Pre-Market Notification Staff at the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH). In this role, Rosecrans was responsible for implementing administrative and regulatory policy for the 510(k) Program, the 513(g) Program, Classification and Reclassification, de novo petitions and other premarket regulatory requirements. Rosecrans’ accomplishments include drafting guidance documents and regulations regarding the 510(k) program, training staff, and assisting in the implementation of the Medical Device User Fee Modernization Act (MDUFMA) and Food and Drug Administration Modernization Act (FDAMA). Rosecrans’ extensive experience at CDRH, and specifically the 510(k) office, enabled her to become one of the nation’s leading experts on the program. Rosecrans’ tenure also allowed her to play a pivotal role in the program’s development and reform. Rosecrans has represented and spoken on behalf of CDRH in multiple forums, including national conferences, FDA advisory committee meetings, and international symposiums. Her published work includes numerous guidance and regulatory documents. She has also worked collaboratively with CMS and other regulatory agencies.
Mike Ryan is a Regulatory Advisor at the FDA’s Center for Devices and Radiological Health (CDRH) in the Office of Device Evaluation (ODE) with 12 years of regulatory experience. Mike leads various regulatory projects on premarket review policy, including the 510(k) device modifications policy, and advises FDA staff and industry on CDRH’s premarket program. Prior to his role as a Regulatory Advisor, Mike served as a lead reviewer and biomedical engineer in ODE for six years.
Vice President, Quality Assurance and Regulatory Affairs
Joseph (Joe) Sapiente is Vice President of Quality Assurance and Regulatory Affairs, Surgical, Breast and Skeletal Health, for Hologic, Inc. Prior to joining Hologic, Joe served as Vice President, Quality Operations and Compliance at Medtronic where he was responsible for quality and regulatory compliance, continuous improvement and supporting new product development and innovation. Over the last 34 years, he has a proven track record of establishing regulatory and quality programs that are key elements of a strategic plan, and directing regulatory programs that result in thorough submissions with accelerated approvals. Prior to Medtronic, Joe spent eight years with Covidien as a Vice President, and before that, he was at Tyco HealthCare and US Surgical where he held progressive roles in both quality, regulatory, clinical affairs and professional medical education and training.
Director of the Center for Devices and Radiological Health (CDRH)
Jeffrey E. Shuren became the director of the Center for Devices and Radiological Health at the Food and Drug Administration (FDA) in January 2010. He previously served as Acting Center Director, beginning in September 2009. The center is responsible for assuring the safety, effectiveness, and quality of medical devices; assuring the safety of radiation-emitting products (such as cell phones and microwave ovens); and fostering device innovation. Dr. Shuren received his B.S. and M.D. degrees from Northwestern University under its Honors Program in Medical Education. He completed his medical internship at Beth Israel Hospital in Boston, his neurology residency at Tufts New England Medical Center, and a fellowship in behavioral neurology and neuropsychology at the University of Florida. He received his J.D. from the University of Michigan. Dr. Shuren has held various policy and planning positions within FDA from 1998 to 2009, including acting deputy commissioner for policy, planning, and budget; associate commissioner for policy and planning; special counsel to the principal deputy commissioner; assistant commissioner for policy; and medical officer in the Office of Policy.
Nancy Singer founded Compliance-Alliance LLC in 2004 to specialize in the professional development for government, association and business professionals. She has taught over 1700 people how to improve their communication practices. She is on the faculty of George Washington University Medical School and Health Science Program, and she has taught classes at Johns Hopkins University, University of Southern California, and Harvard Symposia. Previously she served as Special Counsel for the Advanced Medical Technology Association. For her efforts to improve communication between the government and the regulated industry, Nancy received Vice President Gore’s Reinventing Government Hammer Award and the FDA Commissioner’s Special Citation. She began her career as an attorney with the United States Department of Justice doing litigation for FDA enforcement cases. Subsequently she was a partner at the law firm of Kleinfeld Kaplan and Becker. Nancy is a retired commander in the Naval Reserve.
Federal Trade Commission
Jon Miller Steiger is the Director of the East Central Region of the Federal Trade Commission, based in Cleveland, Ohio. The East Central Region covers consumer protection and education issues for Delaware, Washington DC, Maryland, Michigan, Ohio, Pennsylvania, Virginia, and West Virginia.
He received his law degree from Columbia Law School, and then clerked for Judge Avern Cohn in the U.S. District Court for the Eastern District of Michigan. Jon started his legal career at the Federal Trade Commission’s headquarters, in Washington, DC. He returned home to Cleveland in 2001, with his wife and two children, staying with the FTC as a litigator before becoming Assistant Regional Director in 2005, and Director in 2009.
Executive Vice President, Medical Device International Services
Kim Trautman has over 30 years of experience in medical device quality systems and international regulatory affairs. She is focused on expanding international regulatory affairs and compliance services for NSF’s medical device clients, including expanding medical device training services worldwide and spearheading the development of an independent, third-party regulatory certification program.
Ms. Trautman was previously Associate Director for International Affairs in the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) where she led the CDRH’s international efforts and initiatives. She was responsible for writing the current U.S. FDA Medical Device Quality System regulation and preamble published in 1996. She also developed and implemented the extensive quality system regulation roll out and training programs, and led continuing harmonization efforts with ISO 13485.
Director, Regulatory Affairs
April Veoukas is Director, Regulatory Affairs in Abbott Laboratories’ Quality & Regulatory corporate division. During her more than twenty years at Abbott, she has held positions in research and development, technology acquisitions, and regulatory affairs. In her current position, she has responsibility for a cross-business forum comprised of regulatory leaders, representing Abbott in trade associations, regulatory intelligence, and formulating company responses to proposed regulatory policies.
April earned a juris doctorate from DePaul University College of Law and a bachelor of science in biology magna cum laude from Loyola University of Chicago. She holds a Certificate in Health Law from DePaul University College of Law. April is a member of the Regulatory Affairs Professional Society (RAPS) and the industry co-chair of the AdvaMed 510(k) Working Group and the AdvaMed Benefit-Risk Subgroup.
Divisional Vice President of Medical, Clinical, Quality and Strategic Support
Monica joined Abbott in 2007 and provides strategic support and technical expertise to the medical device Divisions within Abbott. Prior to joining Abbott, Monica worked for the Food and Drug Administration (FDA). In her 12 years of FDA related experience, she held the positions of Medical Device National Expert, Compliance Officer, Medical Device Specialist, and Investigator. Prior to FDA, her career included 14 additional years of employment in the regulatory, computer, healthcare, and pharmaceutical industries holding the positions of Research Assistant, Quality Control Technician, Microbiologist, Supervisor, Manager, Specialist, Director, and Consultant. Monica has a bachelor's degree in microbiology from the University of Texas at Austin.
CEO and President
Jim Wulfeck is the founder and President of the The Mastery Institute and the creator of GMP Mastery™, a 21st century strategy for making GMP a value-adding business strategy.
Jim created the GMP Institute in 1977, and grew it to be the world leader in helping food, drug, medical device and cosmetic manufacturers embrace the challenge of complying with the Food and Drug Administration’s Good Manufacturing Practice (GMP) Regulation.
Since 1977, Jim has traveled the world consulting, developing and conducting GMP training workshops, and performing GMP audits that positively influence the business performance and results of manufacturing organizations in the United States, Puerto Rico and over 70 countries. Examples of his published training programs include: “GMP Makes Good Business Sense”; “GMP – Why Do We Need It?”; “The Ten Principles of Good Manufacturing Practice”; “GMP – The Best Way To Comply”; “Written Procedures – Our Roadmap To Quality”; “Write It Down – Keep Good Records”; “Doing The Job Right The First Time”; “Check And Double Check”; “Keep It Clean” and “Auditing For Compliance and Improvement”.
Ombudsman, Office of Regulatory Affairs
Jessica L. Zeller is the Office of Regulatory Affairs (ORA) Ombudsman at the U.S. Food and Drug Administration and has held this position since its inception in 2015. She is responsible for informally addressing concerns, complaints, and disputes arising between ORA and external parties, including industry, government entities (federal, state, territory, and tribal), and other members of the public. Ms. Zeller began her career at FDA in 2004 as a litigation attorney in the Office of Chief Counsel and subsequently was the deputy director of the Office of Compliance and Enforcement at FDA’s Center for Tobacco Products. Before returning to FDA as ORA ombudsman, Ms. Zeller spent two years as lead FDA attorney for Procter and Gamble. She holds a Bachelor of Science University Scholar degree (biology) from Xavier University and J.D. and M.A. (bioethics) degrees from the University of Virginia.