5th Annual ComplianceOnline Medical Device Summit 2020

Adam E Saltman MD PhD is a Medical Officer in the Office of Compliance, Center for Devices and Radiological Health, at the Food and Drug Administration. He has worked with the FDA in both the premarket and postmarket arenas as a clinical reviewer since 2008. His primary responsibilities there now focus on the compliance medical device removal and correction process, as well as incorporating clinical benefit risk evaluations in recall and potential recall situations. Dr. Saltman consults regularly on clinical risk evaluations, device recall classifications, and public-facing FDA and manufacturer communications. Dr. Saltman left his clinical practice in cardiothoracic surgery in 2016, during which he held a special interest and key opinion leadership in the surgical treatment of atrial fibrillation. He has published more than 100 peer-reviewed articles, served on several journal editorial boards, and conducted competitively funded research projects. Dr. Saltman also holds an appointment of Clinical Associate Professor of Surgery at the Ohio University Heritage College of Osteopathic Medicine, where he teaches residents and medical students. He received his MD and his PhD degrees from Columbia University, his MS in health informatics from the University of Illinois at Chicago, and is certified as a Quality Improvement Associate by the American Society for Quality.

Dr. Anupama Govindarajan is a Nanotechnologist-Engineer and Regulator with a passion for enabling the translation of medical devices from proof-of-concept to safe clinical use – particularly for patients with unmet needs. She received her Ph.D. in Electrical Engineering from the University of Washington in Seattle in the area of micro and nano technologies for biomedical implants.

Her work experiences in the medical-device field over the last fifteen years have been enriched by closely participating in the diverse viewpoints of different stakeholders across many cultures: large companies like Lockheed Martin, startups, academia, research institutions with vast budgets (A*STAR Singapore), and funding organizations & non-profits. In these positions, she has held several technical-leadership positions in the development of miniaturized active implantable devices, paper microfluidics and point-of-care diagnostics for resource-limited settings.

In her recent role as a lead reviewer in The Division of Neurological and Physical Medicine Devices (DNPMD) in the US Food and Drug Administration (FDA), she has often led the review of several complex and novel first-in-human medical devices involving management of interdisciplinary review teams across the FDA. Her experiences have focused heavily on device design, stimulation safety, clinical trials and regulation of Neurostimulation devices. In 2016, she detailed as Senior Policy Advisor with CDRH Innovation (Office of Center Director). CDRH Innovation’s mission is to enhance patient access to innovative and critical medical devices. Toward this mission, she helped craft regulatory support strategies promoting early-feasibility and first-in-human studies for pediatrics, NIH SBIR programs, micro- and nano- technologies in medicine, and for philanthropic-award grantees developing translational medical devices.

Dr. Govindarajan serves on the FDA’s Nanotechnology Task Force Standards sub-committee & the CDRH Pediatric extrapolation for devices (PEDs) team. She co-founded the Neuromodulation Discussion Group at CDRH/FDA. Having worked in medical device development and regulation internationally – across industry, academia and government, she understands the crying need for patient safety and investigations of recalls in the field. She looks forward to her new role as Recall Branch Chief and hopes to take on leadership roles in the development of a reliable global medical-device ecosystem.

Stephen Weitzman has been involved in healthcare matters for the past 45 years as a practicing lawyer and science consultant in the pharmaceutical, medical device, and food industries. He is a pioneer of the use of computers in legal and science research and litigations support systems from mainframe to personal computers. In the early 70’s he set up complex litigations support systems for fortune 100 corporations and their associations in the FTC nutrition advertising proceeding. Those systems blended data from exhibits, attorney files, science literature, surveys, and court decisions, including text and image files. He worked with Brower Murphy who created the first CD-ROM for data on a Toshiba music disc player, the Library of Congress Catalog as Library Corporation. Steve created the first CD-ROM on a government agency (FDA) in 1984, including internal FDA documents and manuals relating to training drug reviewers to enforcement manuals. He also built the FDA’s original website section on regulation enforcement.

In recent years he has also been involved in prosecuting major civil fraud litigation and patent infringement. The fraud litigation involved drug diversion and potential counterfeiting. The patent matters relate to information technology systems.

Currently focuses on the Medical Informatics for healthcare issues related to establishing a functional national health information infrastructure for sharing medical records for research, safety surveillance, and personalized medicine.

Rita Hoffman, RAC. Managing Partner Regs & Recall Strategies, LLC .Ms. Hoffman has more than 36 years of FDA experience across the device, drug and veterinary industries. She has an intimate understanding of FDA regulatory and compliance issues from the perspective of both FDA and regulated industry. As an FDA compliance consultant, she provides clients with regulatory insight, advises on critical compliance deficiencies, performs compliance and new product audits, provides insight and guidance on recall strategies to the medical device industry, and advises on jurisdiction determinations for combination products.

Ms. Hoffman retired from the FDA in January 2011 as the Recall Branch Chief for the Center for Devices and Radiological Health (CDRH), where she was responsible for oversight and review for all medical device recalls. Ms. Hoffman held several positions including the Center for Drug Evaluation and Research (CDER) Jurisdiction Review Officer (providing guidance on drug/device product designation, combination products and co-packaging), Acting Associate Ombudsman, Small Business Liaison, and was a Policy Analyst for eight years in the Office of the Commissioner. She served as co-chair of RAPS’ Baltimore/Washington Metropolitan Area Chapter for 2-terms, and in 2008 was presented with the Special Recognition Award by RAPS.

Roy Wallen leads Directional Healthcare Advisors, LLC as its CEO. He has served in leadership roles for new product initiatives for more than 25 years in medical technology companies ranging from pre-revenue start-up to multi-billion, global concerns. With an undergraduate degree in electrical engineering and a biomedical focus, as well as graduate studies in biomedical engineering and business, Roy has spent his career managing existing businesses for sustainable profits and bringing new technologies out of the laboratory and into clinical use. He has led successful commercial launches of new healthcare technologies in the United States, Europe, and Asia. Roy has published 13 peer-reviewed papers and 20 abstracts and short papers related to healthcare technology and its implementation.

Peter Pitts is President of the Center for Medicine in the Public Interest. A former member of the United States Senior Executive Service, Peter was FDA's Associate Commissioner for External Relations, serving as senior communications and policy adviser to the Commissioner. He supervised FDA's Office of Public Affairs, Office of the Ombudsman, Office of Special Health Issues, Office of Executive Secretariat, and Advisory Committee Oversight and Management. He served on the agency's obesity working group and counterfeit drug taskforce and is a Special Government Employee (SGE) consultant to the FDA's Risk Communications Advisory Committee.

Specific areas of global policy expertise include FDA policy and process, healthcare technology assessment and reimbursement issues, biosimilar development, Rx-to-OTC switching, risk management plans, GMP policies, pharmacy education programs, drug safety, DTC/ItP, Critical Path, personalized medicine, clinical trial transparency, IP protection, FDA reform, drug importation, counterfeiting, genetically modified food issues, food safety and security, recalls, nutritional labeling.

In 2010, he was named by Modern Healthcare magazine as one of the 300 most powerful people in American healthcare.”

His comments and commentaries on health care policy issues regularly appear in The New York Times, The Los Angeles Times, The Washington Post, The Wall Street Journal, The Financial Times, Health Affairs, The Boston Globe, The Washington Times, The Chicago Tribune, The Chicago Sun Times, The San Francisco Examiner, Investor's Business Daily, The Baltimore Sun, The Economist, Nature Biotechnology, The Journal of Life Sciences the BBC World Service, Fox News, and The NewsHour with Jim Lehrer, among others.

Brian Shoemaker provides consulting services and training in computer system validation, software quality assurance methodology, and electronic records and signatures. His projects have included validating process-equipment software, validating embedded medical-device software, developing software quality systems, assisting companies through regulatory-compliance projects, and evaluating systems for 21 CFR Part 11 compliance. His clients have included firms in the medical-device fabrics manufacturing, plastics molding, contract lyophilization, outsourced medical device engineering, clinical trial software development, dental prosthetics, and bone-repair implant fields. He has worked with companies in Germany and Switzerland as well as the U.S.

Previous to founding ShoeBar Associates, Brian served as Quality Assurance Manager at PPD Informatics (now CSS Informatics), QA/Validation for Doxis, Inc., and Systems Engineering Manager at Behring Diagnostics, Inc. Brian earned his Ph.D. in chemistry from the University of Illinois; he has achieved the ASQ Software Quality Engineer certification.

Kwame Ulmer is a MedTech executive with nearly twenty years of experience in government and the private sector. He is currently an Angel Investor and regulatory strategy consultant with a focus on MedTech and Venture Capital firms. Mr. Ulmer previously served as Vice President, Regulatory Affairs and Quality Assurance at Implant Direct, a Danaher Corporation Operating Company. He led efforts to shorten global registration timelines, improved product quality by process optimization and achieve best-in-class department engagement scores. Kwame has served in progressive leadership roles at the US Food and Drug Administration (FDA) where he ran operations of a seventy four - person division. Kwame has personally evaluated over 1,000 medical technologies.

Mike has over 30 years’ experience developing medical devices and systems. Over his career he has been in charge of safety & efficacy testing and Regulatory & Clinical strategies. He has also served as a technical advisor/consultant in the medical device industry for over 25 years, giving him exposure to both large medical device companies and startups.

Mike has taught college for over 25 years and has contributed/participated on many domestic and international technical committees. He holds a Ph.D. in Physical Chemistry from the University of Southern California/California Institute of Technology.

Larry is a professional speaker who can train persons on all aspects of FDA requirements, and practical and successful solutions to FDA problems. He has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems; prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel. Finally, he is a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public.

Is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Robert is a Cyber Risk senior manager and has over 15 years of experience with information technology, regulatory compliance, and business process & technology controls across various industries. He has served his clients in a wide range of cyber risk roles which included: security, privacy, and compliance assessments; developing cyber strategies / roadmaps / programs based on leading industry requirements (HIPAA, NIST, ISO, PCI, SOX, etc.); backfilling for strategic security roles within organizations; and leading security work streams on large scale, multi-million dollar business transformation efforts and enterprise resource planning technology implementations.

Robert is also a portfolio leader for Deloitte’s Medical Device Safety and Security (MeDSS) practice. In this role, he focuses on helping life science and healthcare clients address security of medical devices throughout their product lifecycle.

Robert received a Bachelor of Arts degree in Economics from the University of California, Los Angeles. In addition, he holds numerous certifications including the Certified Information Systems Security Professional (CISSP), Certified Information Systems Auditor (CISA), and Certified Cloud Security Professional (CCSP).

Daphne Walmer is a former Director of Technical Communications at Medtronic who pioneered the use of electronic manuals in the medical device industry. Her group obtained approval to test eIFUs in the European Union for 10 years before their approval in 2013. She helped review the EU regulation for the industry, and led the effort for Medtronic to comply with its requirements. She currently consults in the areas of management of user documentation, translation and localization, and component content management systems.

Marisa White is the Regulatory Misconduct & Complaints Lead CSO for the Division of Bioresearch Monitoring (DBM) in the Office of Compliance at FDA's Center for Devices and Radiological Health (CDRH). Marisa started at the FDA in the International Operations Branch under the Office of Regulatory Affairs (ORA), where she was involved in the coordination of FDA foreign inspections as the Bioresearch Monitoring (BIMO) Program Team Lead. Prior to FDA, Marisa worked at the New York Blood Center as a Research Assistant before becoming a Clinical Research Program Coordinator at Johns Hopkins University in the Oncology Department, where she managed data and regulatory requirements for various multi-center protocols, with coordinating center responsibilities. Marisa also served as a Sr. Research Program Coordinator for the Leukemia Research Group with responsibilities for training and SOP writing/updates. After Hopkins, she held several roles at a clinical research organization (Covance, Inc.), one of which was a Clinical Research Associate (CRA) involved the set-up and monitoring of clinical trials. Marisa holds a BS in Biotechnology & minor in Biochemistry from Rutgers University and a CCRP certification from SoCRA.

BAKUL PATEL is Associate Director for Digital Health, at the Center for Devices and Radiological Health (CDRH), at the Food and Drug Administration (FDA). Mr. Patel leads regulatory policy and scientific efforts at the Center in areas related to emerging and converging areas of medical devices, wireless and information technology. This includes responsibilities for mobile health, health information technology, cyber security, medical device interoperability, and medical device software.

Mr. Patel is the FDA liaison between the Federal Communications Commission (FCC) and the Office of the National Coordinator (ONC). Since its inception in 2013, Bakul chairs the International Medical Device Regulators Forum (IMDRF) “software as a medical device” working group, a global harmonization effort.

Before joining FDA, Mr. Patel held key leadership positions working in the telecommunications industry, semiconductor capital equipment industry, wireless industry and information technology industry. His experience includes Lean Six Sigma, creating long and short-term strategy, influencing organizational change, modernizing government systems, and delivering high technology products and services in fast-paced, technology-intensive organizations.

Mr. Patel earned an MS in Electronic Systems Engineering from the University of Regina, Canada, and an MBA in International Business from The Johns Hopkins University

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.

One of the foremost thought leaders in IT, French Caldwell has been decisively shaping the GRC market for the last 12 years.

French is a former Fellow and Vice President at Gartner where he led their GRC research, including the influential Gartner Magic Quadrant on GRC, as well as research into disruptive technology. He also worked with the White House and U.S. Naval War College in 2002 to develop the Digital Pearl Harbor war game, the first ever strategic assessment of cyber war strategies. In 2012, the game took on a very real form with the strategic attacks on oil and gas infrastructure in Saudi Arabia and Qatar. French is also a retired naval officer and a nuclear submariner. Post-retirement, French served as a diplomatic liaison to NATO for the post-Cold War Congressional Commission on Roles and Missions of the Armed Forces.

As an academic, French served as a Federal Executive Fellow at the Brookings Institution, an Adjunct Fellow at the Center for Strategic and International Studies, and an Adjunct Professor and Graduate Research Advisor at the George Washington University School of Engineering Management. He has written a book on international law, and has over 400 published research papers.

French has a PhD in Law and Policy, an MA in International Economics, Strategy and Diplomacy, and a BS in Oceanography.

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety and Turnarounds. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers, Public Health Service. Positions include Chief Compliance Officer, http://morflearning.com/angelabazigos/, QA Director, Director of MIS. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx. Patent on speeding up software compliance https://www.google.com/patents/US8266578 . Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ . Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.

Terri Jollymour is a member of the Operations Readiness & Convergence (ORC) enterprise group, leading strategic efforts in the convergent space for Johnson & Johnson (J&J). Terri works across the three main business sectors: Consumer/McNeil, Janssen Pharmaceuticals, and Medical Device & Diagnostics to ensure safety, quality and sustainability for the convergent space.

Within J&J's Convergent Space, Terri is responsible for comprehensive engagement with project teams to assess and mitigate new product development for product, process and program risks. This spans across early to late development and pre-launch readiness. Terri is also accountable for strategic leadership initiatives in the Supply Chain organization, such as leading the implementation of the Combination Product CGMPs. Terri's group is responsible for ad hoc support for convergent programs, to address specific issues or fill in specific roles on teams. Her group is also responsible for rapid tactical reponse for supply chain and/or quality and compliance mitigation issues across the enterprise. Terri leads the Convergent Network at J&J, which brings all three business sectors together for learning, sharing/leveraging and networking within this innovative space.

For over a decade, Terri has held top leadership roles in the convergent space within J&J. She has been responsible for leading large, complex, convergent product development program teams within J&J's pharmaceutical and medical device & diagnostic sectors. She has been recognized for her outstanding leadership with numerous company recognition awards and executive programs.

Terri earned her degree in Pharmacology at the University of California, Santa Barbara. Prior to J&J, she worked in the diagnostic space at Syva and led controlled release drug-delivery programs (combination products) at ALZA Corporation. She held positions of increasing responsiblities within program management, R&D, analytical sciences and quality assurance over her many years in the health care industry. She is a member of the Healthcare Businesswomen's Association and is a certified Project Management Professional. Terri is married and has three children and three dogs! She enjoys swimming with her masters team, cycling, hiking and skiing. She resides in Northern California.

Mr. Levinson is a start-up medical device executive with over 30 years of experience developing and bringing revolutionary new products to market. Mr. Levinson started Cerebrotech Medical Systems in 2011 based on a technology developed at UC Berkeley with the goal of improving care for brain injury patients with a noninvasive monitor to detect early stages of cerebral edema and bleeding. Mr. Levinson was the start-up President and CEO for Zeltiq Aesthetics, brought in by the investors, Frazier Healthcare Ventures and Advanced Technology Ventures, as the company's first employee. Zeltiq's groundbreaking cooling technology was licensed from Massachusetts General Hospital for non-invasive fat layer reduction. Mr. Levinson built the company from the ground up and launched the product 3 years later, in what has become widely regarded as one of the most successful medical device launches in the aesthetic space. Zeltiq has quickly become the world's premier fat layer reduction technology and is found in thousands of physician offices in the US and around the world. Zeltiq held its IPO in October of 2011 and by 2014 exceeded a market cap of $1 billion. Prior to Zeltiq, Mr. Levinson was the first technical employee at Thermage, where he led the product development as its founding Vice President of Research and Development. Thermage utilizes a radiofrequency-based technology and was the first device to provide non-invasive skin tightening. That company held its IPO in 2006, and has become a mainstay in aesthetic dermatology and cosmetic surgery physician practices. It is now part of Valeant Pharmaceuticals. Mr. Levinson was also the founding Vice President of R&D at BioSurgical Corporation, developer of a novel applicator for fibrin sealant, acquired in 2000 by Baxter International. Mr. Levinson has served as a product development executive at Nellcor (patient monitoring), Baxter (in vitro diagnostics), and as an engineer at ALCOA Intercon-X, and Hewlett Packard. Many of Mr. Levinson's innovations are represented in his 37 issued U.S. patents with more pending. He earned his B.S. in Engineering Sciences from University of California at San Diego and also holds a MS in Computer Systems from University of Phoenix.

Kevin has over 30 years of senior executive experience in the Health Care, Financial Services, Technology and Professional Services Industries in roles including CEO, President, COO, Managing Director and Senior Partner.

• Newport Board Group - Partner 2013 - Current
• Managing Director of Nationwide Healthcare & Life Sciences Consulting Practice with 29 professionals, most former CEO's. Overall firm has nearly 100 partners nationwide.
• ePAY Healthcare - Acting CEO and Board Member (2013 - Current)
• Nationwide Healthcare IT SAAS Company with operations in 42 states serving over 650 Hospitals, Ambulatory Surgical Centers and other providers.
• Comprehensive Patient Responsibility Financial Management Platform to maximize patient revenue collections and introduce innovative lending and other financing options.
• Responsible for all primary aspects of the company.
• Leads/Directs M&A Buy and Sell, IPO, Capital Raising and other events.
• Serves as a Board member for US Community Behavioral Health, a nationwide provider in Behavioral Health and Traumatic Brain Injury Post-Acute Care Rehabilitation.
• Performs strategic Board and CEO level consulting and advisory projects for clients.
• Paradigm Outcomes - CEO 2006 - 2012
• Nationwide Catastrophic Injury and Chronic Pain management full service and risk taking Healthcare Accountable Care Organization (ACO)
• Served also in progressive capacities as Board Director, President, CFO & COO
• Orchestrated a highly successful turn around and monetization of the company.
• Electronic Data Systems - Managing Director 2003-2006
• Executive Leader for a very large strategic business unit serving the healthcare and financial services industries. Clients included Blue Shield, McKesson, UCSF Medical, HSBC, Visa and Citigroup.
• Achieved significant top line and bottom line growth while securing key new logo revenue clients.
• Ernst & Young - Senior Partner 1980 - 2000
• Coordinating Partner for major accounts including Healthnet, Foundation Health, Bank of America, Wells Fargo and others. One of the youngest partners in the firms history.
• Chairman and executive leader of a very successful nationwide M&A and post merger integration practice
• Professional Groups - Bay Area Alliance of CEO's, Financial Executives Institute (FEI), AICPA & California CPA Societies.

Eduardo Cervantes is President and CEO of Morf Media, a leading compliance training system vendor which is enabling the Millennial, and subsequent generations to effectively train on compliance. Previously, Eduardo led several successful exits through M&A in the technology industry domestically and in Europe. He started his career in M&A with Goldman Sachs where he worked major consumer and pharma transactions. Eduardo holds an MBA and an MS from the University of Texas at Austin.

Susan W. Neadle is a member of Janssen's Global Product Quality Leadership and is a Design Excellence Black Belt. Her accountabilities span from leading Janssen's Combination Product Center of Excellence to creating new quality frameworks for emerging platforms and technologies, Design-to-Value, criticality analysis and risk management, and Quality Engineering for Janssen's portfolio of products.

Over her extensive career, Susan has played integral leadership roles in the product and process development of over a dozen new products. She was awarded the Johnson Medal, Johnson & Johnson's highest honor for innovation excellence, for invention and development of a product platform central to J&J Vision Care's portfolio. This technology was also awarded the "SILMO Award" for Innovation, Technology & Creativity in Europe, and the "Good Design Award" in Asia.

Susan's experience includes enabling and applying advanced product and process analytics to drive proactive process capability and product quality. She is a core-team member of the J&J Convergent Technologies Network. She has been recognized for her contributions in CTQ Flow-Down, DTV and PLM Initiatives, to drive improved robustness in product quality through the end-to-end lifecycle management.

Susan earned an M.S. in Polymer Science & Engineering, and a B.S. in Biology/Chemistry, and Fellowships in the American Academy of Optometry and the British Contact Lens Association. Prior to joining J&J, she held R&D, quality, and commercialization positions at Unilever, Organon Teknika, and IBM. In these positions she worked in controlled release technology, biomedical diagnostics, and materials analysis.

In addition to Susan's professional experience, she holds numerous patents, has written a variety of papers, and has frequently presented on topics related to her contributions to, and areas of subject matter expertise in, the medical device and pharmaceutical industries.

Ms. Rasooly is the Founder and CEO/ President of PuraCath Medical -- a medical device startup in home dialysis and was spun out of Stanford University during her graduate school education in 2012. Ms. Rasooly has over twelve years of experience in R&D in medical device and biotech industries. She is focused on revolutionizing the dialysis industry and bringing her novel home dialysis technology to make dialysis at home safer and more affordable. Prior to being the Founder and CEO of PuraCath Medical, she was a researcher at the renowned Molecular Imaging Laboratory at Stanford University School of Medicine, where she worked on stem cell therapy and imaging projects. Julia has obtained a B.Sc. in Bioengineering from the University of California Berkeley, an M.S. in Bioengineering from Stanford University, an M.S. in Medicine from Stanford University, and a Certificate from the Summer Institute for Entrepreneurship from the Stanford Graduate School of Business (GSB). She took a "“leave-of-absence" from her PhD program in Bioengineering from Stanford University to grow PuraCath on a full-time basis. She has won multiple honors and awards, including the Howard Hughes Medical Institute Medical Scholar, the National Ford Foundation Pre-Doctoral Fellowship, the National Coca-Cola Scholarship, and multiple other governmental grants and awards for start-up ventures. She also is the co-founder and President of two non-profits focused on tech entrepreneurship as well as women entrepreneurs in healthcare.

Jon is the Co-founder & VP of QA/RA at greenlight.guru, a software company that produces beautifully simple quality management software exclusively for medical device companies. He is also the founder of Creo Quality, a consultancy that specializes in assisting startup medical device companies with product development, quality systems, regulatory compliance & project management. Jon started his career in the medical device industry over 16 years ago as a product development engineer after receiving his BS in chemical engineering from Rose-Hulman Institute of Technology.

Computer System Validation's principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications.

He has completed more than 230 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.

Matt Matuszewski is currently Director Marketed Combination Product Quality, in the Janssen Quality organization. In this role, he provides Quality Engineering leadership and oversight to collaborate with Supply Chain and other key stakeholders to ensure quality improvement opportunities for marketed Combination Products are identified, prioritized and executed in a manner that meets business needs. He is also responsible for the use of quality principles and tools, including process owner for Product Risk Management, outlining the end to end product risk management execution of the Janssen product portfolio.

Matt has over 30 years of cross-functional, cross-sector experience at Johnson & Johnson including Quality, Supply Chain and Research & Development leadership roles in Medical Devices, Pharmaceuticals, and Consumer Products.

Most recently, Matt drove Strategy and Execution, in the Janssen Supply Chain (JSC) organization, partnering to translate strategy to action, driving implementation of our customer-focused vision. In medical devices, he led the Design to Value (DTV) Strategy in Global Surgery R&D where he led cross functional teams to embed the principles of DTV into their New Product Development processes across the ten Global Surgery companies to improve the effectiveness of new product launches and product lifecycle management. Matt was also an R&D leader at Ethicon managing R&D for several electromechanical product teams. Prior to Ethicon, Matt was with Independence Technology, LLC. At this J&J startup, he was responsible for the Supply Chain and New Product Development functions working with external partners which led to the development, manufacture and launch of the innovative iBOT® Mobility System.

Before his role in Medical Devices, Matt was in the Pharmaceutical and Consumer sectors where he held roles of increasing responsibility in Supply Chain and Process Excellence. While with the Pharmaceuticals group, he led the Lean Manufacturing implementation and black belt project teams at our manufacturing plant in Gurabo. With the Consumer Products group, Matt held various Supply Chain roles, including Product Supply Lead where he led successful new product introductions for our Clean and Clear brand.

Matt has a B.S. in Mechanical Engineering from Rutgers University, and a M.S. in Management and an M.S. in Mechanical Engineering, both from the Massachusetts Institute of Technology.

Michael A. Swit focuses on solving the legal challenges confronted by the pharmaceutical, medical device, and other life sciences industries in tackling the myriad of legal mandates enforced by the U.S. Food & Drug Administration. Mr. Swit has extensive experience counseling life sciences firms on the demands of compliance with FDA's statutory and regulatory requirements to develop and market safe and effective drugs, biologics, medical devices, IVDs and other products. He also has advised regulated firms on a wide range of FDA regulatory matters, including drug and device approvals and marketing/promotional claims, dietary supplement health claims and regulatory issues in corporate acquisitions. His experience includes FDA development strategies, compliance and enforcement initiatives, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts.

Mr. Swit has been addressing critical FDA legal and regulatory issues since 1984. Before joining Duane Morris LLP, Mr. Swit served for seven years as vice president at a preeminent scientific and FDA regulatory consulting firm, where he developed and ensured execution of a broad array of regulatory and other services to clients, both directly and through outside counsel.