March 19th - 20th, 2015
San Diego, CA
Medical Device Conclave 2014
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Speakers

Robert J. Russell
President of RJR Consulting, Inc

Robert J. Russell, (Bob) is the President of RJR Consulting, Inc., a Global Regulatory Consulting company, specializing in understanding regulatory issues for the pharmaceutical, medical device and combination products industry. Bob has more than 30 years of experience working with FDA, EMA, Healthcare Authorities and Agencies across Latin America, Middle East and Asia / Pacific supporting clients projects in these regions. Licensing, registrations, GMP, DMFs and borderline products are core competencies of the Course Director.

Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 manufacturers of Drugs and Medical Devices. RJR's offices are located in every major region with in-country experts on staff handling local regulatory needs. Bob has a BS and MS in Chemistry.
Edwin L Bills
Principal Consultant , Bilanx Consulting LLC

He has over 20 years experience in the field of quality and regulatory affairs.Recently, Mr. Bills served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical devices and is a current member of the committee.Currently he is the Principal Consultant at Bilanx Consulting LLC in the area of medical device quality, regulatory, product liability and risk management.Mr. Bills has also provided expert services to legal counsel in the area of risk management and FDA compliance.
Len Valenti
Senior Compliance Expert, FDA Group

Len Valenti, is the sole proprietor of Valtech LLC, with 30 years of FDA experience working for the U.S. Food and Drug Administration (FDA) in both headquarter Centers and Field. As an FDA team member, Len served as a chemist and a compliance officer in CDER, CFSAN, CDRH, ORA CVM and the Office of the Commissioner. Using his strong technical knowledge of GLPs, GMPs, QSR, HACCP, QSIT, ISO standards, and PIC/S (Pharmaceutical International Convention/scheme), he developed regulations and policies for drug safety, non-clinical laboratory testing, bio-terrorism, drugs, import procedures, and medical device performance standards. Mr. Valenti originated compliance decisions on non-clinical studies, drugs, devices and veterinary products, and is an expert on pre-market and post-market importation.
Casper E Uldriks
Former Associate Center Director of FDA's CDRH

Casper (Cap) Uldriks, through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. His comments are candid, straightforward and of practical value. He understands how FDA thinks, how it operates and where it is headed. Based on his exceptionally broad experience and knowledge, he can synthesize FDA’s domestic and international operational programs, institutional policy and thicket of legal variables into a coherent picture.
Harvey Rudolph
HRRM, LLC (Ex-FDA Official, ISO 14971 Standard Co-Author)

Dr. Harvey Rudolph is an independent risk management consultant specializing in process development and training in risk management. He has been a member of the Joint Working Group on Risk Management since it began in 1995 and is a primary author of ISO 14971. Currently he co-chairs the US Technical Advisory Group for that standard and is working on the new ISO risk management guidance document.

His 37 years experience with medical devices include 25 years at FDA, where he held a variety of positions and retired as deputy director of the medical device laboratory. He also worked for seven years at Underwriters Laboratory, where he was the global program manager for medical devices developing programs to help clients deal with the global medical device environment.

He brings a wealth of knowledge and practical experience to this risk management workshop, having trained and consulted for numerous large and small companies throughout the world.
John E. Lincoln
Principal, J. E. Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 30 years experience in U.S. FDA-regulated industries, 16 years as a full-time consultant. John has worked with companies from start-up o Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on all CGMP subjects. John is a graduate of UCLA.
Dr. Gavin Braithwaite
Vice President of Research , Cambridge Polymer Group

Gavin manages the R&D efforts at CPG. He has been working with colloids, surfaces and polymers in solution for over 20 years. He has a B.Sc. in Physics from Edinburgh University, specializing in acoustics and fluids, a Masters in Electronics from Southampton University, specializing in digital radio communication strategies, and a Ph.D. in Chemical Engineering from Imperial College (London), where he worked on adsorbed polymer layers and colloidal stability. For this work, he built and used an AFM to probe the interparticle forces due to adsorbed polymer layers. He is an expert in instrument design, having designed an atomic force microscope for his thesis and a number of custom instruments since joining CPG. He also designed a micro-shear rheometer as part of his post-doctoral research at MIT, where he investigated the rheology of confined polymer solutions and melts. He has a number of issued patents on topics as diverse as an extensional rheometer (now marketed as the CaBER), a method for making biomimetic collagen layers, and on methods for making, and uses for, hydrogels. At Cambridge Polymer Group, he is managing the main research efforts. Gavin has expertise in polymer gel formulation and characterization, and focuses a large part of his research on associating polymer systems. His primary interest is polymers in solution and in colloidal systems.
Peter Pitts
President, Center for Medicine in the Public Interest Former Associate Commissioner, US Food and Drug Administration
  • Special Government Employee, FDA Risk Communications Advisory Committee
  • Associate Editor, Therapeutic Innovation & Regulatory Science (official DIA journal)
  • Executive Advisory Board, the Galien Foundation 
  • Editorial Advisory Board, Food and Drug Policy Forum
  • Advisory Board, Journal of Commercial Biotechnology
  • Editorial Advisory Board, The Patient Magazine
  • Board of Advisors, Digital Health Council
  • Washington Drug Letter, Editorial Advisory Board
  • Briefings on Drug Safety, Editorial Advisory Board
  • Advisory Board, MedAd News
  • Scientific Advisory Council. Animal Health Institute
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.

He has given healthcare policy presentations throughout Europe, Canada, and the United States, as well as in Russia, Saudi Arabia, Lebanon, Israel, Turkey, The United Arab Emirates, Jordan, Kenya, South Africa, Egypt, Algeria, Ukraine, Taiwan, Japan, Brazil, Mexico, Vietnam, and Columbia.

His book, Become Strategic or Die, is widely recognized as a cutting edge study of how leadership, in order to be successful over the long term, must be combined with strategic vision and ethical practice. He is the editor of Coincidence or Crisis, a discussion of global prescription medicine counterfeiting and Physician Disempowerment: A Transatlantic Malaise.

He has served as an adjunct professor at Indiana University’s School of Public and Environmental Affairs and Butler University. A graduate of McGill University, he is married to Jane Mogel, and has two sons.
Lena Cordie
Director - Operations at Key Surgical

Ms. Cordie has over 20 years experience in quality and regulatory affairs in the medical device, call center and retail markets, specializing in integrating electronic QMS modules, implementation of agile labeling programs, including color labels and barcodes, and cleanrooms for medical device production. She has been a member of Regulatory Affairs Professionals Society (RAPS) since 2005.

Key Surgical products focus on Central Sterile Departments and Ms. Cordie represents the company as a voting member of the Association for the Advancement of Medical Instrumentation (AAMI) since 2007. Ms. Cordie is very active in a number of working groups drafting Sterilization Standards related to surgical instrument cleaning and reprocessing and is a US delegate to the ISO/TC 198 Sterilization of Health Care Products committee.
Stan Mastrangelo
Professor, Center for Applied Health Sciences, Virginia Tech University

Stan Mastrangelo, Professor, Center for Applied Health Sciences, Virginia Tech University has 30 years professional work experience with 27 years in management positions in medical device, food, and pharmaceutical industries. He has held positions such as a Senior Quality Engineer, Corporate Quality Assurance Auditor, Plant QA Manager, and QA Director at Abbott Laboratories. Stan was a member of the ANSI Executive Standards Board. Stan has been a member of the ISO Joint Working Group for Risk Management of Medical Devices (that developed ISO/IEC14971). Stan is a committee liaison to the ISO Technical Management Board Joint Working Group on Risk Management developing ISO 31000. This group is developing a Risk Management Standard applicable to a wide range of organizations including industry, government, and non-profit organizations. Stan was on the US PhRMA team that supported the development of ICH Q9 Quality Risk Management for Pharmaceuticals. Stan is also involved in TC 215 JWG7 Risk Management of IT-Networking Medical Devices and a liaison to JWG 3 Software Lifecycle Risk Management. Stan is a frequent speaker for Medical Device and Pharmaceutical industry organizations and has been faculty for organizations such as AAMI (American Ass. for the Advancement of Medical Instrumentation), Advamed,, ASQ, and CPT (Center for Pharmaceutical Training). Stan has been active developing and implementing a Graduate Certificate Program and a Master's of Science Degree Program in Risk Management for the Healthcare Manufacturing Industry at Virginia Tech.
Martell Winters
Senior Scientist - Nelson Laboratories

Martell Winters received a B.S. in microbiology with a minor in chemistry from Brigham Young University. Mr. Winters has been at Nelson Laboratories for 20 years and spent most of that time working in the Radiation Sterilization group, responsible for bioburden testing and radiation validation studies. His specialties include microbiological process validation and radiation sterilization of medical devices, allograft tissue and pharmaceutical products. He is currently a Senior Scientist for Nelson Laboratories.

Mr. Winters serves on many AAMI Sterilization Working Groups. He is also on the AAMI Sterilization Standards Committee and is the AAMI liaison to the AATB Standards Committee. In 1995 he received his Registered Microbiologist (RM) certification, and in 2001 his Specialist Microbiologist (SM) certification in consumer products and quality assurance microbiology from the U.S. National Registry of Microbiologists.