Risk Management for the Full Product Life Cycle: Design Concept through Post-Market Surveillance

Janet Michener Whipple

Janet Michener Whipple is a Partner at Validant specializing in medical devices, In-vitro diagnostics and combination products. With more than 30 years of experience, Whipple has a comprehensive background in global regulatory compliance, quality, design, supply-chain operations, post-market surveillance, audits and inspections, and regulatory intelligence. She has worked with start-up organizations, mid-sized firms and manufacturers within the global top 20 of pharmaceutical and medical device firms. Whipple’s responsibilities have included QA leadership roles, warning letter response and remediation, due diligence, acquisition integrations, facility start-ups, product transfers, plant closures and more. She holds a B.S. in mechanical engineering and an MBA from California State Polytechnic University-Pomona. She is a licensed engineer in California and holds Project Management Professional (PMP), Lead Auditor, Six Sigma Black Belt, and Manager of Quality/Organizational Excellence certifications.

James Wabby

James Wabby, Global Head, Regulatory Affairs-emerging technologies, combination products and devices at AbbVie, has spent more than 20 years in quality operations, compliance, and regulatory affairs. Wabby's areas of expertise include medical devices, technology medicinal delivery platforms, complex generics, companion diagnostics, digital medicine, and combination products. Wabby regularly provides AbbVie regulatory counsel within the quality management system and regulatory affairs. He is a member and chair of various regulatory and quality working groups, a keynote speaker at various regulatory symposia, and a moderator for various global regulatory panel discussions. He is a professor at the University of Southern California ‘s school of pharmacy. He also leads sections of the RAC- Devices exam prep course. Wabby holds a B.S. in biology and an MHMS in health law and policy from Duquesne University. He also holds a certificate in health law and life science regulatory compliance from Seton Hall University’s law school and the RAPS’ executive development program from Northwestern University.

Heather Rosecrans

Heather Rosecrans, Executive Vice President, Medical Devices & Combination Products, brings more than 40 years of public-health and medical-device experience, including more than 30 years at the FDA. She provides strategic consulting services and works with Greenleaf clients to deliver innovative devices. Before joining Greenleaf, Heather served as Director of the 510(k) premarket notification staff at the FDA’s Center for Devices and Radiological Health CDRH . In this role, she was responsible for implementing administrative and regulatory policy for that program; the 513(g) program, classification and reclassification; de novo petitions; and other premarket regulatory requirements. Heather started her FDA career as a biologist in the Bureau of Medical Devices. She served on the CDRH’s premarket application staff, where she coordinated the administrative, scientific, and regulatory review of PMAs, as well as product development protocols, master files and associated submissions. Rosecrans also served as a consumer safety officer. She ultimately became director of the 510(k) staff. She also was pivotal in developing the 510(k) Program. Her published work includes numerous guidance and regulatory documents. She has also worked collaboratively with the Center for Medicare and Medicaid Services and other regulatory agencies. Rosecrans holds a B.S. in biology from Pfeiffer College in Misenheimer, N.C.

Daniel Schultz

Dr. Daniel Schultz is the Principal of medical devices & combination products at Greenleaf, which he joined following a distinguished 35-year career devoted to supporting and advancing Americans’ public health as a physician, teacher, FDA official, and member of the Public Health Service. He has been recognized many times for his contributions and dedication to public health. At Greenleaf, he provides strategic consulting services and works with clients to bring safe and innovative devices to patients. As Director of the FDA’s Center for Devices and Radiological Health, Dr. Schultz led seven FDA offices and more than 1,000 employees. He oversaw development, implementation, and evaluation of medical device and radiation-emitting products. He began his 15-year FDA career as a medical officer at the CDRH and eventually rose to become Director of the FDA’s Office of Device Evaluation. Dr. Schultz previously served on the surgical staff at the National Naval Medical Center. He earned his B.S. from the City College of New York and his M.D. from the University of Pittsburgh.

Richard Vincins

Richard A. Vincins, RAC, is Vice President, global regulatory affairs for Oriel Stat a Matrix. Vincins has more 30 years of medical industry experience, including worldwide regulatory compliance efforts for medical device, IVD, and pharmaceutical companies. His resume includes stints at C.R. Bard, Medtronic, and bioMerieux, where he established everything from quality systems to ISO standards, worked on 510(k) submissions and CE marking of multiple product lines. Vincins is a chartered quality professional, ASQ certified medical device auditor, and certified quality auditor. He holds a B.S. and M.A. in biomedical biology from Bridgewater State College.

John Love

John Love, VP, Training and Development at Oriel STAT A MATRI, has spent more than 20 years working on regulatory standards, including MDSAP, the EU’s MDR, and the FDA’s QSR and MDD. Love is an expert in training, production and process controls, CAPA, auditing, and risk management. He has managed training for a mobile-fluoroscopic imaging manufacturer, worked on implementing unique device identification requirements, and oversaw the development and implementation of internal auditor training and certification. Love’s auditing expertise spans the globe—from the US, to Japan, to China and the EU. He holds has a B.A. in elementary education with an emphasis in Spanish and an M.S. in instructional technology from Utah State University.

Julien Senac

Dr. Julien Senac is the Global Director of the IVD Focus Team at TÜV SÜD, where she oversees development of the IVD field with a focus on IVDR. Dr. Senac’s role is to engage with all stakeholders and to coordinate activity, growth, and resources across the company’s operations. Dr. Senac’s background is in biomedical research. After more than a decade working at the bench in biomedical research at the Mayo Clinic, the NIH, and other major institutions, Dr. Senac also worked with multiple biotech start-ups focused on oncology and gene therapy. He found this new career in the medical device quality and regulation by joining a notified body, where he conducted audits and reviewed technical documents for numerous medical devices. Dr. Senac also worked on the IVDR designation and performed the design dossier assessment of in vitro diagnostic devices. By joining TÜV SÜD, Dr. Senac further fulfilled his passion for quality, safety, and regulation. He holds a Ph.D. in molecular and human genetics from Baylor College of Medicine.