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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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Early Bird $400.00 Member | $500.00 Nonmember
8/15/2020 –8/29/2020 Regular $500.00 Member | $600.00
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David E. Chadwick, PhD, RAC, FRAPS
Cook Medical, Bloomington, IN
I have over 25 years of experience in the medical device industry in such areas as basic research and development, clinical research, and for the past 20 years, regulatory affairs/quality assurance. The scope of my experience includes the product areas of dermatology, in vitro diagnostics, urology, cardiology, ENT devices, drug delivery, electrosurgery, cardiovascular stents and catheters. I spent many years in research and development functions and managing clinical trials prior to transitioning into regulatory affairs. My primary focus resides in medical devices and combination products, but my experience also expands into drug regulation and submission.
I currently serve as the Director, Regulatory Science for Cook Medical. In this role, I provide high-level regulatory and clinical advice on pre- and post-market safety, quality, performance, testing, compliance and marketing issues pertaining to medical devices globally. Over my regulatory career, I have been responsible for registration, compliance and complaints. I have served as the company’s regulatory and clinical focus person for post-market activities and customer feedback.
I have extensive experience as an instructor at the Medical School level in Human Anatomy/Embryology and Histology. Additionally, I have experience at the undergraduate and technical school levels in Anatomy/Physiology and Cell Biology. I am a recognized lecturer for the Regulatory Affairs Professional Society and other organizations on a local, national and international level.
I am a member of the RAPS Board of Directors. I serve as the Industry Representative to FDA’s Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee.
I graduated with a B.S. in Biology from Albright College, and graduated with a Ph.D. in Anatomy and Cell Biology from the School of Medicine, University of Pittsburgh. I have been recognized as a Fellow (FRAPS) and hold the RAC certification.
Andrea Gadsby, Cook Inc., Director, Quality Assurance.
Christie has over 25 years of experience in the in vitro diagnostic medical device (IVD) industry. With a degree in clinical laboratory science, she began her career in hospital clinical laboratories. Upon moving into industry, Christie worked in various quality and compliance roles at small and startup companies where she established their quality management systems (QMS) compliant with ISO 9001, ISO 13485, and FDA QSR requirements. To learn other aspects of the industry, Christie led commercial and post-launch phases for a molecular test as a Product Manager before moving into Regulatory Affairs where she developed and executed domestic and international regulatory strategies for IVD instruments, software, and multiplexed assays (protein and molecular). After many years in various roles in industry and earning her master’s in public health degree in epidemiology, Christie moved into consulting where she continues to leverage her experience and knowledge to determine elegant solutions for clients’ QMS and regulatory affairs challenges.
Larry Pool, Cook Inc., Director, Post Market.
I am a Medical Device Quality Consultant who loves working with product development and QA/RA teams to help implement and execute their QMS. I've spent most of my career as an engineer in new product development setting up processes and leading teams as an energetic unit that can be relied upon for meeting deadlines, working together, and enjoying our work. As an engineer working with customers at Greenlight Guru, nothing beats helping others reach their goals and bring their ideas to market.
Mark DuVal, J.D., is President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries.
His practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training and interfacing extensively on behalf of companies with the FDA with relation to product approvals and clearances, clinical trial negotiations, approvals, policy arguments, appeals, etc.
Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems working both domestically and internationally.
He was on assignment for 3M Health Care Systems, Ltd. In Europe based out of the United Kingdom. He then worked at Medtronic in Corporate Compliance for FDA, Anti-kickback, False Claims Act, HIPAA & HITECH, and other advice related to the FDA-regulated industry.
Mark earned his Juris Doctor from the William Mitchell College of Law where he served as executive editor on the law review, and his Bachelor of Arts in Public Administration from St. Cloud State University. Mark has served on various boards including the Minnesota BioBusiness Alliance, Minnesota Biosciences Council, The Food and Drug Law Institute and has been a former Chairman of the Minnesota State Food, Drug, and Medical Device Section of the Minnesota State Bar Association. He is also on the Board of Advisors of the Masters in Regulatory Affairs Services program at St. Cloud State University.
Mark is a frequent national speaker and writer on issues relating to product approvals/clearances; combination products, product advertising and promotion, Anti-kickback and False Claims Act (reimbursement) matters.
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