Xavier Health
QA/RA Institute for Medical Device Professionals
 

Upcoming Courses
At-A-Glance

Expert Faculty

Julius Aviza

Quality Director, Allergan

Julius has been engaged in the medical device industry for over 15 years with varying degrees of responsibility and functional management. He has directed activities in CAPA, Design Control, Risk Management, Management Control, Audit, Training and Document Control. His medical device experience spans from re-architecting quality systems to restructuring and optimizing quality organizations for large medical device companies.

Over the past 7 years, Julius has primarily focused on compliance and remediation efforts. Currently, Julius is a Quality Director at Allergan, and prior to that position, he was the Senior Director of Quality leading Quality Engineering efforts for both new product development, and post-market quality activities. Julius holds a Bachelors degree in Science and a Masters degree in Business Administration.

Pat Baird

Product Design Owner, Baxter Healthcare

Pat Baird is a Product Design Owner at Baxter Healthcare, with oversight responsibility to $400M+ in fielded product. His previous roles included software developer, function manager, program manager, and engineering department manager. He has published and presented on topics ranging from software development to change management to stakeholder management to risk management. He is currently the co-chair of the AAMI Infusion Pump Standards committee, chair of the Assurance Case Technical Information Report Working Group, a US representative to the IEC standards committee, and is one of the founders of the Infusion Systems Safety Council. He is pursuing a Masters in Healthcare Quality and Patient Safety at Northwestern University.

Gina Brackett

Compliance Officer, Cincinnati District Office, FDA (invited)

Gina Brackett has been with the Food and Drug Administration since 1990. Prior to taking the compliance officer position, she was the Medical Device Specialists in the Cincinnati District Office for 7 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’s degree in Chemistry.

Bill Brodbeck

Director, Regulatory Affairs, Steris

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.

Patrick Caines

Director, Product Surveillance, GE Healthcare

Patrick is Director, Product Surveillance, GE Healthcare, where he is responsible for the company’s global post market surveillance and associated quality systems. He has more than 20 years quality management experience for both medical devices and clinical diagnostics and served as Director, Corporate Post-market Surveillance, Boston Scientific and Quality Director, Ortho Clinical Diagnostics, Johnson and Johnson. He holds a Ph.D. in Clinical Biochemistry from the University of Windsor, Ontario, Canada as well as a MBA from St. John Fisher College, Rochester, New York.

 

Richard Chapman

Chief, General Hospital Devices Branch in the Office of Device Evaluation (ODE) of the Center for Devices and Radiological Health, FDA (Confirmed)

MR. Chapman had 25 years of product and software development experience as developer and manager in the medical device and other industries before joining FDA in 2005. He was a reviewer in ODE, General Hospital Devices Branch, for over 2 years before transferring to the Division of Electrical and Software Engineering in the Office of Science and Engineering Laboratories. In 2010 he transferred back to ODE as Chief of General Hospital Devices Branch. He specializes in software-based medical devices, medical devices with embedded software, infusion pumps, and new methods for regulatory review of premarket submissions. His medical device industry experience includes software development for infusion pumps, implantable defibrillators, heart rate monitors, respiratory test equipment, portable blood gas analyzers, dietary assessment software, and wild animal telemetry devices. He has a Masters Degree in Software Engineering from the University of Minnesota and is currently working toward a PhD. Degree in Computer Science.

Maria Cianciotto

Principal Partner, Quality System Architects

Maria Cianciotto has held Quality, Regulatory and Clinical Affairs leadership positions within the Medical Device industry for over 20 years, including positions at GE Healthcare as the VP of Clinical Affairs and the VP of QA/RA. Maria is currently a Principal Partner with Quality System Architects, which specializes in providing expert Quality and Regulatory consulting through a combination of advisement, hands-on assistance and training. Specific areas of expertise include QA/RA strategic planning and organizational design, overall quality system development and implementation, employee training, inspection readiness, remediation under enforcement actions and regulatory agency interactions. Maria is dedicated to the education of the QA/RA professional and has pursued her passion to provide learning opportunities through her involvement as a member of the Board of Directors for Xavier University’s QA/RA Institute, as a strategic committee member for Xavier’s annual MedCon event, and as a course developer for the World Medical Device Organization. Maria is also an author of Quality books and articles, including “Inspection Awareness – A Guide to Achieving Quality System Readiness.” Maria received her Bachelor of Science in Biology and her Life Sciences teaching credentials from the University of California, Riverside. Maria has also completed Masters work in QA (with a Quality Systems Concentration) at Southern Polytechnic University, GA.

Jay Crowley

Senior Advisor for Patient Safety, FDA

Jay Crowley. Senior Advisor for Patient Safety, Center for Devices and Radiological Health (CDRH), FDA.

Jay Crowley is Senior Advisor for Patient Safety, in FDA’s Center for Devices and Radiological Health. He is interested in developing and implementing new methods and techniques for identifying and resolving problems with the use of medical devices. Jay has held variety of positions over his 20 years at FDA. Currently, Jay has responsibility for implementing the Unique Device Identification requirements of the 2007 FDA Amendments Act. He holds a master’s degree in risk analysis and a bachelor’s degree in mechanical engineering.

Kathleen Cummings

Nurse Consultant, Office of Surveillance and Biometrics., Center for Devices and Radiological Health, FDA

Barbara Fant

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.

Pavan Kumar Garikapati

Regulatory Domain Head, Medical Devices, Wipro Technologies

Pavan is a Regulatory, Quality and IT Compliance professional with about 20 years of experience. Pavan currently heads the Regulatory domain practice for the Medical Devices business unit at Wipro Technologies. He has expertise in US, Europe and emerging market medical device regulations. Pavan is a certified Six Sigma Black Belt and certified lead auditor for Quality Management Systems. He has given consultancy to more than 50 companies in the field of Quality and Regulatory domain. In his current role, Pavan manages the Post-Market Surveillance offerings to various medical device companies.

Pavan earned his Master’s in Manufacturing Engineering and Industrial Engineering. He also has a Bachelor’s Degree in Mechanical Engineering. Pavan has presented and published several papers in both national and international forums.

Laureen Geniusz

Medical Device Specialist, FDA

Laureen has been with the FDA since 1990.  Laureen has extensive experience conducting medical device inspection for both domestic and international firms. Laureen is also a medical device performance auditor for FDA investigators, as well as assisting the accreditation of third party persons from Industry.  Laureen has conducted numerous industry presentations and has worked with other government agencies such as FBI, US attorney’s office, CDC and DOJ.  She is a graduate from Bowling Green State University.

Ralph Hall

Counsel, Faegre Baker Daniels

Ralph Hall has extensive experience in the areas of FDA, health care law and corporate compliance, including the application of those regulatory systems to the medical device industry. He has expertise in the design and implementation of regulatory compliance programs and with FDA enforcement actions. Ralph also has experience in developing and implementing cross disciplinary corporate legal strategies, corporate law department organization and management, and general corporate counseling.

Prior to rejoining Faegre Baker Daniels, Ralph was with Guidant Corporation where he served as Senior Vice President and Deputy General Counsel – Litigation and Compliance. Also at Guidant, he was Special Counsel to the Board of Director’s Compliance Committee and the corporation’s Compliance Office. Earlier, Ralph was General Counsel of Guidant’s Cardiac Rhythm Management Group — a billion dollar plus business. Before joining Guidant, Ralph was with Eli Lilly and Company where he served in a number of legal roles, including chief environmental counsel.

Ralph also serves as a Professor of Practice at the University of Minnesota Law School where he teaches courses in FDA law, corporate compliance and negotiation. Ralph has written extensively on FDA and compliance matters, as well as spoken frequently at legal seminars on a variety of subjects.

Linda Hoffman

Consumer Safety Officer, Office of Surveillance and Biometrics. Center for Devices and Radiological Health, FDA

William Huff

Public Health Analyst, Office of Surveillance and Biometrics. Center for Devices and Radiological Health, FDA

Soma Kalb

Acting Director, IDE Program, FDA

Soma Kalb, PhD, is the acting director of the IDE program at the CDRH within FDA. Dr. Kalb received her BS in electrical engineering from the University of Maryland in 1995, her MSE in biomedical engineering from the Johns Hopkins University in 1997, and her PhD in biomedical engineering from Duke University in 2004. She has been with the FDA since 2005, where she began as a research scientist and reviewer of post-market medical device reports. Since 2007, Dr. Kalb has been in the Office of Device Evaluation, first as a reviewer in the Division of Cardiovascular Devices, and now as the Acting Director of the IDE Program. Dr. Kalb has been involved in both review of clinical trials as well as policy development and implementation for CDRH.

Sharon Kapsch

Chief, MDR Policy Branch, Office of Surveillance and Biometrics. Center for Devices and Radiological Health, FDA

Sharon Kapsch has been with the FDA for 35 years, and is currently the Chief of the MDR Policy Branch in the Center for Devices and Radiological Health (CDRH).   The MDR Policy Branch is responsible for the establishment, interpretation, and enforcement of the regulatory requirements for Medical Device Reporting (MDR).  In addition the branch provides education and guidance to the medical device community to facilitate awareness and understanding of the reporting requirements.

Michelle Keyzer

Product Development and Engineering Manager, Baxter

Michelle Keyzer is a Senior Manager in Systems and Compliance Engineering Research and Development, with responsibilities across Baxter Electro-Mechanical Devices. Her previous roles have included software and systems engineering, functional management, program management, and ownership of device design verification processes including test method development and test method qualification. She has published and presented on topics ranging from software development metrics, operations research, design verification and validation, test method development  and change management. She holds Bachelor of Science degrees in Computer Engineering and Applied Computational Mathematics, Master of Science degrees in Operations Research and Statistics, and an MBA.

Mark Kramer

RAC, President, Regulatory Strategies, Inc.

Mark D. Kramer, RAC, is President, Regulatory Strategies, Inc., a regulatory consultancy specializing in medical devices and combination products.  He has more than 25 years’ experience in regulatory affairs, including 17 years at the US Food and Drug Administration culminating in his position as Director of FDA’s Office of Combination Products from 2002 to 2007. From 2007-2010, Mark was Vice President, Regulatory Affairs and Chief Regulatory Strategist at GE Healthcare, where he had executive responsibility for US, Canadian and Latin American regulatory affairs for the medical device business.  Mark is on the Board of Directors of the Regulatory Affairs Professional Society (RAPS), served as Chair of the Wisconsin RAPS Chapter from 2007-2010, and is an adjunct faculty member for St. Cloud State University’s Master’s program in regulatory affairs.

Tina Krenc

Director, R&D Quality Assurance, Abbott Molecular

Ms. Krenc is the Director, R&D Quality Assurance at Abbott Molecular Division. She started at Abbott in 1982 in Research and Development working on the hepatitis product lines. In her 30 years at Abbott, Tina has had experience in clinical research, operations support, and 15 years of Quality Assurance experience in multiple quality organizations. She was the project coordinator for developing and implementing a worldwide design control quality system and risk management process for Abbott Diagnostics Division. Tina is very involved in Risk Management internal and external to Abbott. She serves as member of ISO/TC 210/SC 62A Joint working group on Application of Risk Management to Medical Devices. In addition she is a Risk Management Subject Matter Expert for ISO/TC212 In-vitro Diagnostics Technical Committee. She also is a participant on several CLSI subcommittees, including the EP-23 Education Working group. She has presented risk management to the FDA and at International meetings, as well as at CLMA, and for ADVAMED.  Tina received her Masters of Science in Product Design and Development from Northwestern University School of Engineering in 2006 and currently teaches a risk management and decision making course for Northwestern’s Master of QARA program

William MacFarland

Director, Division of Enforcement B, Office of Compliance, FDA/CDRH

William MacFarland is the director of the Division of Enforcement B within the Office of Compliance. In this position, he is responsible for overseeing the division’s 33 member review staff who review PMA Manufacturing Sections, Establishment Inspection Reports, recall classifications and compliance cases.Previously, Mr. MacFarland worked in CDRH’s Office of Device Evaluation as both a reviewer and Deputy Division Director in the Division of Cardiovascular Devices. Prior to his current work at FDA he was a consultant with Quintiles Consulting where he was responsible for providing clients with strategic regulatory guidance and managed their 510(k), PMA and IDE projects. Additionally, he developed medical product test strategies, provided review of non-clinical protocols and reports, and provides guidance on compliance with Design Controls throughout medical device development. Mr. MacFarland has also worked for Angiosonics, Inc. of Morrisville, NC as Director of Regulatory Affairs.

Mr. MacFarland received his MBA from University of Maryland in College Park, MD, and his MS in Biomedical Engineering from Case Western Reserve University in Cleveland, OH.  He received his BS in Electrical Engineering from Clarkson University in Potsdam, NY. Currently he maintains a Professional Engineers license in Maryland and is an ASQ Certified Quality Engineer, Certified Biomedical Auditor, Certified Software Quality Engineer, Certified Six Sigma Black Belt, Certified Manager of Quality/Organizational Excellence and Certified Reliability Engineer.

Laurel Macomber

Product Expert, BSI

Laurel Macomber, MS, PMP, RAC, is a product expert for the EU Notified Body, British Standards Institution (BSI), and has more than 25 years of experience in medical device R&D, program management, and quality systems development for both large and small firms; working on orthopedic, neurosurgical, cardiovascular, and spinal products.

During her career, she has held numerous engineering positions including director, Program Management Office.

Brian Motter

World-Wide Vice President, Quality and Compliance, DePuy Synthes

Brian has 24 years industry experience with 21 of that in medical devices.  His primary function has been quality systems and operations management. The size of companies he has worked with has ranged from the large established company to the small start-up and have been on both ends of the supply chain. Specialties:  Six Sigma Blackbelt, Lean Manufacturing, Job Shop and Short Run Manufacturing.

Steve Niedelman

Former FDA Deputy Associate Commissioner, Lead Quality System & Compliance Consultant, King & Spalding

Steve 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.

Bill O’Connell

Senior Quality System Expert, King & Spaulding

(formerly Associate Director of the Division of Enforcement II, Office of Compliance of the CDRH)

Jim O'Reilly, JD

Professor, University of Cincinnati

Professor Jim 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 45 texts and 180 articles since 1977.

Phil Phillips

President, 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.

Phil Pontikos

National Device Expert, FDA (invited)

Mr. Pontikos joined the FDA in 1994 as an Investigator in the Brunswick, Ohio Resident Post of Cincinnati District. In 2000, Mr. Pontikos moved to the Columbus, Ohio Resident Post where he currently resides. Mr. Pontikos was promoted to the Cincinnati District Medical Device Specialist position in October 2006. In January 2010, Mr. Pontikos became one of the National Experts in Medical Devices. Mr. Pontikos is a Level II Certified Medical Device Investigator and Performance Auditor performing inspections in program areas such as medical devices, pharmaceuticals, and bioresearch monitoring. He has participated as a course instructor for numerous FDA courses including Computer Aided Inspections, Basic Medical Device, and the Industrial Sterilization course for Drugs/Devices. He has also served as a District Trainer for new hires and as a District Trainer for software applications such as OASIS and FACTS. Phil has a Bachelor’s degree in physics from Kent State University.

Nancy Pressly

Office of Surveillance and Biometrics. Center for Devices and Radiological Health, FDA

Eugene Reilly

Public Health Analyst, Office of Surveillance and Biometrics. Center for Devices and Radiological Health, FDA

Eugene Reilly is a program analyst in FDA’s Center for Devices and Radiological Health (CDRH) Office of Compliance and works on the systems that process, display, and analyze compliance and enforcement information. Eugene has been with the FDA’s Center for Devices and Radiological Health in the Office of In Vitro Diagnostic Device Evaluation and Safety as a clinical reviewer and compliance officer and the Office of Surveillance and Biometrics working with adverse event information.

Catherine Ricketts

Nurse Analyst, FDA

Catherine Ricketts is a Nurse Consultant in Product Evaluation Branch I (PEB I), Division of Postmarket Surveillance (DPS), Office of Surveillance and Biometrics (OSB), Center for Devices and Radiological Health (CDRH).  Her primary responsibilities include reviewing and analyzing Medical Device Report (MDR) data to identify and monitor potential device safety and performance issues.  Catherine is a graduate of Georgetown University’s School of Nursing and a Veteran of the US Army Nurse Corp. Prior to joining the FDA in 2012; Catherine worked in multiple care settings including Hospital settings in GYN-Oncology and Medicine, Outpatient Reproductive Endocrinology and Infertility offices and in management roles in Long Term Care and Home Health arenas.

Susan Rolih

Senior Vice President, Regulatory Affairs and Quality Assurance, Meridian Bioscience, Inc.

Susan Rolih has over 25 years of experience in the in vitro diagnostic device (IVDD) industry. Since joining Meridian Bioscience, she has been responsible for the regulatory and quality units 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. She also has served as instructor and advisory board member for medical laboratory specialist programs at the University of Cincinnati and Georgia State University.

Heather Rosecrans

Senior Regulatory Advisor, Greenleaf Health, LLC.

Heather Rosecrans brings more than 30 years of public health and medical device experience to Greenleaf Health LLC. 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.

Richard Roy

Postmarket Surveillance Director, GE Healthcare

Richard (Dick) Roy has served a number of companies in Complaint management, currently as a Postmarket Surveillance Director at GE Healthcare. Dick has 16 years of experience managing Complaint Investigation and Adverse Event Reporting processes to meet worldwide regulatory requirements with other medical device manufacturers. Dick brings experience in other compliance organizations, and has previously served in roles in engineering, manufacturing, and finance. He has been directly involved in FDA inspections and Notified Body, PMDA, and other audits. Dick holds a Bachelor of Science degree in Mechanical Engineering from the University of Wisconsin, as well as a Master of Business Administration from the University of Michigan.

Victoria Schmid

Office of Surveillance and Biometrics. Center for Devices and Radiological Health, FDA

Marjorie Shulman

Director, Premarket Notification 510(k) Program, FDA

Marjorie Shulman, MBA, Director, Premarket Notification 510(k) Program, Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) within FDA, has served at CDRH since 1984. Before serving on the 510(k) staff she was on the Premarket Approval Staff. Shulman is also the reclassification/classification coordinator for CDRH. Some of her 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), FDA Modernization Act (FDAMA) and the Food and Drug Administration Safety and Innovation Act (FDASIA). Shulman has worked on numerous policy setting groups within the FDA. Most recently she has been very active with the 510(k) Working Group whose mission it is to evaluate the 510(k) program and explore actions CDRH could take to enhance 510(k) decision making. Shulman holds an MBA from Hood College.

FDA TBA

Food and Drug Administration,

Paul Teitell

Cincinnati District Director, FDA (Confirmed)

Paul Teitell became the District Director of the Cincinnati District Office in January 2012; and he has been employed with Food and Drug Administrations field operations for thirty-four years.  Mr. Teitell was Denver District’s Director of Investigations Branch; and prior to that he served at the Denver District Director’s Special Assistant.  Mr. Teitell was also the Supervisory Consumer Safety Officer in the Salt Lake City Resident Post of the Food and Drug Administration; and he was the Resident in Charge at FDA’s Albuquerque, New Mexico Resident Post.  Mr. Teitell has also been an operating field investigator in FDA’s: Richmond, Virginia Resident Post; and Salt Lake City, Utah Resident Post. An interesting note, Mr. Teitell has a history of supporting and representing FDA during several Olympic Games.  He coordinated FDA’s support of the 2002 Winter Games in Salt Lake City, was part of a U.S. Department of State team assisting the Government of Greece for the 2004 Summer Games in Athens and was invited by the Peoples Republic of China to assist their preparations for the 2008 Games in Beijing.

April Veoukas

Director, Regulatory Affairs, Abbott

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.

Deb Yoder

Nurse Consultant, Office of Surveillance and Biometrics. , Center for Devices and Radiological Health, FDA