Instructor Biographies
Instructors: All speakers are highly qualified and have extensive experience in the medical industry. Experience and credentials include, FDA QSR/GMP, Design Control, Risk, Software, Submissions, Former FDA Investigator & Advisor, European Notified Body, ISO Committee Members, and Specialists in Software Quality Assurance, etc...
Rich Basler A specialist in the Medical Device industry since 1976, Rich has been involved with the Quality function of medical device manufacturing including extensive experience in Quality Assurance, Regulatory Compliance, and Regulatory Submissions for a number of medical device companies. Rich has assisted numerous companies from start-ups to Fortune 100 corporations in developing quality systems compliant with US FDA and International standards, including achievement of ISO 9001 registration and CE Mark approval for the European Union in addition to FDA Quality System Regulation compliance. On the regulatory side, Rich has extensive experience in Pre-Market submissions for new products and for clinical evaluations. His successful submissions span many fields of medicine, including such areas as disposable nasal dilators, implantable and disposable prostate and urological devices, tracheotomy devices and a wide range of laparoscopic access and surgical instruments. A retired US Navy Commander, Rich graduated from the University of California, Berkeley, with a Bachelor of Arts degree and later received a Masters of Business Administration. He is a co-founder and former Board member of the Orange County Regulatory Affairs Group located in Orange County, California. He is a past Editor of the American Society for Quality (ASQ), Orange Empire Section Newsletter, the SCOPE. Rich is a Certified Quality Auditor under both the Registration Accreditation Board (RAB) and the ASQ.
Corrine Bonfiglio has over twenty years of accomplished quality assurance, regulatory and clinical affairs experience. She offers in-depth experience with FDA & ISO regulatory requirements, including quality system compliance, submissions (510(k), PMA, and CE Marking) and clinical trial development. She assists medical device manufacturers with compliant quality system implementation, auditing and training. Corrine has extensive experience with regulatory strategies and submission of IDE's, 510(k)'s and Master Files as well as import/export approvals for medical devices and biologics. As an international quality system specialist, Corrine has assisted numerous manufacturers to become compliant with the U.S. FDA, the State of
Brian J. Donatois an attorney with the Washington, D.C. based law firm Hyman, Phelps & McNamara, P.C. Before joining Hyman, Phelps & McNamara in 1991, Mr. Donato practiced law in firms he founded in Virginia and in Florida. In the period from 1976 to 1980, he served as General District Court Judge for Albemarle County, Virginia. He was Chief Judge for all of the General District Courts in the Sixteenth Judicial District of Virginia for the years 1978 and 1979. He was appointed to the position of Lecturer at the University of Virginia Law School for 1978 through 1988. Since 1982, he has been a faculty member at the University's Annual Trial Advocacy Institute. He is the recipient of an FDA Commissioner's Special Citation for his work in helping FDA communicate with members of the regulated industries. He is also the recipient of awards from FDLI, RAPS and The Orange County Regulatory Affairs Discussion Group. In January of 2001, he received The William J. Brennan, Jr. Award from The University of Virginia School of Law for his efforts in teaching trial tactics and techniques at the law school's annual Trial Advocacy Institute. Mr. Donato has made numerous presentations to a variety of trade associations including the Drug Information Association, American Society of Quality Control, FDLI, RAPS and CTFA about various regulatory issues affecting their membership. Mr. Donato is also the author of a number of papers and articles on federal and state regulatory law issues. His practice includes providing information about various legal issues related to the Federal Food Drug and Cosmetic Act and FDA's regulations and similar laws and regulations of the State of California. He is a graduate of Manhattan College (1963) and the University of Virginia Law School (1970). From 1963 to 1967 he served as a line officer in the United States Navy on active duty. Thereafter, he continued to serve in the United States Naval Reserve, retiring in 1988 with the rank of Captain. He is admitted to practice in the states of California, Virginia and Florida, and in the District of Columbia.
Cindy Ellis is Staff Integration Engineer for Advanced Sterilization Products, Division of Johnson & Johnson, a medical device manufacturer headquartered in Irvine, California. Ms. Ellis has been in the medical device industry for over 20 years, including 11 years in in vitro diagnostic development and nearly 10 years in software verification and validation. For the past four years, she has been responsible for ensuring Advanced Sterilization Product's adherence to ISO and FDA QSRs for software. During this time she has had a lead role in searching for and selecting an electronic document control system that meets the requirements of 21 C.F.R. Part 11. In a new, expanded role, she is also responsible for establishing a formal reliability engineering group for ASP. Ms. Ellis holds a B.S. degree from the University of California at Irvine, where she majored in Biological Sciences, and will complete her M.S. degree in Quality Assurance from California State University, Dominguez Hills in December. She has received certifications from the American Society for Quality as a Certified Software Quality Engineer (CSQE), Certified Quality Engineer (CQE), and Certified Reliability Engineer (CRE). She currently serves on ASQ's exam preparation committee for the Software Quality Engineer certification exam.
Leo Eisner, P.E. specializes in helping clients through the product safety and international regulatory processes (CE Mark, Canadian Medical Device Regulations (CMDR), etc.). The firm specializes in Medical, In Vitro Diagnostic, and high tech devices. Assistance to clients is provided in the interface with the Safety Agencies, preparing the product for testing, support is also provided in many aspects to obtain CE Marking and CMDR including preparation of technical files, training on the product safety standards, directives and quality standards, and creation and implementation of quality systems. Leo has over 18 years experience working for some of the Premier Third Party Safety Test Agencies and is a registered Professional Engineer in the Safety Engineering discipline. He worked at Underwriters Laboratories (UL) for 9 years in a wide variety of product categories, and then joined TÜV Product Service for several years specializing in electrical medical products. He later joined Karl Storz Imaging and was their Compliance Engineer in charge of all product submittals to Third Party Test Agencies for product safety and EMC; CE Mark for the Medical Device, Low Voltage and EMC Directives; and was in charge of the Engineering Quality System. Leo is a co-author of the MD&DI article "A Primer on IEC 60601-1" published September 2003. He holds a B.S. in Electrical Engineering from San Jose State University and an M.B.A. from Santa Clara University. Leo is a member of RAPS, AAMI, ASQ & IEEE.
Marc Goodman is a specialist on issues and strategies related to U.S. Food and Drug Administration (FDA) software compliance with emphasis in software verification and validation, software quality assurance, software development procedures, and project planning and management. Mr. Goodman has developed software for critical and non-critical medical devices, manufacturing and test software, laboratory information systems, information systems and work flow control for clinical laboratories, data communications, real-time data base access and many aspects of medical devices for over a 15 year period. Mr. Goodman has consulted on products and processes for all Classes of Medical Devices and Levels of Concern. For over 20 years, Mr. Goodman has pursued software engineering for not only the medical device and FDA related industries but also real-time process control and data communications software development for telecommunications, utilities, and aerospace industries. He is a member of the Institute for Electrical and Electronic Engineers (IEEE) and the IEEE Computer Society. Mr. Goodman holds a Masters in Computer Science and a Bachelors in Economics from the University of Pittsburgh.
Rita Hoffman is the Recall Branch Chief for the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), responsible for the oversight and review for all medical device recalls submitted for health risk classification. Ms. Hoffman provides guidance to FDA District Recall Coordinators on recall recommendations initiated by regulated industry and on recall strategy (Recall Depth, Effectiveness Check, and Audit Check), Health Hazard Evaluations, recommendations and legal authority. In more than 30 years with FDA, Ms. Hoffman has worked on many aspects of agency compliance and policy in the areas of drugs, devices and veterinary products. Prior to joining CDRH, she was the Center for Drug Evaluation and Research (CDER) Jurisdiction Review Officer, providing guidance on drug/device product designation, combination products and co-packaging. In addition, she was involved in regulatory compliance in the area of pharmacy compounding. Rita has held various other positions within CDER including Acting Associate Ombudsman, Small Business Liaison, serving as primary contact for inquiries from the ORA Small Business Reps, as well as working as a Policy Analyst for eight years in the Office of the Commissioner. During her tenure with FDA, Ms. Hoffman has received a number of FDA awards including the Leveraging and Collaboration Award, Commendable Service Awards and Outstanding Recognition Awards. In 2008, Mrs. Hoffman received the Regulatory Affairs Professional Society Special Recognition Award recognizes unique contributions and achievements of individuals and organizations that advance the quality of health and regulatory affairs. In addition to her work with FDA she serves as co-chair of RAPS’ Baltimore/Washington Metropolitan Area Chapter, working in collaboration with both chapter members and FDA to increase professional awareness of regulatory issues. Ms. Hoffman holds a BS in speech pathology and audiology from the University of Maryland, advanced courses in Chemistry and Public Policy and is Regulatory Affairs Certified. Rita R. Hoffman, RAC Branch Chief CDRH Recall Branch, HFZ-306 Division of Risk Management Operations Office of Compliance Center for Devices and Radiological Health (CDRH)
Robert Kanaley currently is a Quality Systems Advisor at Guidant Corporation’s Temecula facility, an ISO certified company providing interventional cardiovascular products worldwide. He is responsible for coordinating quality system development within the Quality Organization and across Guidant business units. In the past, he has been a group leader for software validation, a Section Leader of the Quality Engineering Department and a Product Development Engineer at Guidant Corporation. During this time Robert has developed a strong background in Quality Systems and ISO Requirements and is currently heading the group’s Part 11 compliance effort. Additionally Bob is a member of the AdvaMed (HIMA) Part 11 Working Group and the Industry Coalition on Part 11. Prior to his employ at Guidant Corporation Robert has worked in the pharmaceutical field with SVP and LVP manufacturing equipment and also machine design for consumer products. Robert holds a Bachelor of Science degree in Mechanical Engineering from Villanova University.
David M. MacKenzie has over 25 years of experience in the design and program management of medical, industrial, and aerospace products. He specializes in Hazard Analysis, risk assessment & software safety. Mr. MacKenzie has lectured in conjunction with the FDA on the design of safe microprocessor systems, Hazard Analysis, and the design & validation of international medical products. He is a U.S delegate to ISO/IEC JTC1/SC7/WG9 on Software Integrity and is an ISO Lead Assessor. Mr. MacKenzie has developed validation protocols for products in medical, industrial, and aerospace markets, which successfully led to the introduction of several multimillion dollar product lines. Mr. MacKenzie has designed numerous instrumentation products and developed unique methods for validating software safety. He has worked extensively with domestic and international regulatory agencies, and has established an organization for the design and approval of international medical devices. A member of several professional organizations, including the American Society for Quality Control (ASQC), and the Institute for Electrical and Electronic Engineers (IEEE); Mr. MacKenzie graduated from the California Institute of Technology with a B.S. in Electrical Engineering specializing in Solid State Physics, and has completed graduate work in Integrated Circuit Design at the University of California at Irvine.
Stan Magee Stan Magee is president of Software Engineering Process Technology Company, a firm specializing in the implementation of software process technology for U.S. and international corporations and organizations. Mr. Magee is past convener (1999-2002) of WG 7 (Life Cycle Management) for ISO/IEC JTC1 SC 7 (Systems and Software Engineering) standards group. During his tenure the standard ISO/IEC Standard 15288-System Engineering-System Life Cycle Processes, was developed. He was a U.S. delegate to the International Plenary meetings from 1986 -- 2002. In 1995 he was elected to the IEEE Computer Society Golden Core of 500 people who have significantly served the IEEE Society in standards development over its 50 year history. Mr. Magee is co-author of the books, Guide to Software Engineering Standards and Specifications, Artech House Publishers, 1997, ISBN 0-89006-919-0 and Guide to Standards and Specifications for Designing Web Software, 1998, Artech House Publishers ISBN 0-89006-819-4. He has authored many technical reports relating to software engineering standards issues. In 1997 Mr. Magee was part of a “People to People” quality mission to China and lectured at Shanghai University on software quality standards. He gives seminars on meeting the requirements of ISO 9001/9003 for medical device firms. In 1994 he established a software business and quality system plan, for VNIPI Sport of Moscow, Russia for obtaining ISO 9001 certification. VNIPI is the privatized MIS section of the Russian Olympic Committee. In 2002, Mr. Magee established a plan for the Thailand Government to be in the upper quartile producers of software in the world market place by 2010. Mr. Magee has over 42 years experience in the software field and is considered an expert in the area of software life cycle methodology. He is active on many governmental, educational and professional boards, and holds BS from the School of Engineering from Oregon State University and an MBA in International Business from the University of Puget Sound.
Dan Modi is Assistant Director in charge of the Product Certification Group at Alcon Research, Irvine Technology center. He is responsible for directing EMC, Product safety, environmental testing and other validation activities at Alcon. Dan has wide experience in testing, certification, and design evaluation of products for international markets. Dan has considerable experience working with and training on International Standards and Regulations, in order to help manufacturers understand Global Certification requirements. He is a RAC (Certified Regulatory Affairs Professional through Reguatory Affairs Professional Society), NCE (Certified EMC Engineer through National Association of Radio & Telecommunications Engineers) and CQA (Certified Quality Auditor through American Society for Quality). He is Secretary & Education Committee chair of the IEEE (Institute of Electrical and Electronics Engineers)'s EMC Society TC 8 (Technical Committee on Product Safety) and Vice-chair of TC4 (Technical committee on EMC Control). Dan is also a co-author of the MD&DI article "A Primer on IEC 60601-1" published September 2003.
Brent Noblitt is co-founder and Senior Partner of the consulting firm Noblitt & Rueland. Mr. Noblitt specializes in international and U.S. medical device strategic planning, development, and marketing. His consultation has been used to market medical devices throughout the world. Mr. Noblitt's associations range from start-up ventures to Fortune 100 corporations. His marketing background and technical training allows him to comprehend and advise on the marketing planning process and opportunities of various technologies. Prior to founding Noblitt & Rueland, Mr. Noblitt held management & executive positions in the medical device industry. Mr. Noblitt’s product experience includes various critical care devices, cardiac output computers & pulmonary catheters, extravascular lung water computers, ultrasound devices, phono-angiography, computerized patient databases, patient monitoring systems, disposable & reusable pressure monitoring devices & accessories, ejection fraction computers, continuous mixed venous oxygen saturation systems & catheters, surgical laser systems, implantable defibrillators, pacemakers, continuous blood pressure control systems, as well as, home healthcare delivery systems. His academic training includes a B.S. and M.S. in Electrical Engineering-Biomedical from Purdue University complemented by an M.B.A. degree earned from Pepperdine University and he is a member of ASQC-Biomedical & Healthcare Divisions.
Donna M. Norton is the Manager of Quality Assurance for the Information Services department for Allergan, Inc, a medical device and pharmaceutical manufacturer, headquartered in Irvine, California. Ms. Norton has worked in the medical device manufacturing industry for most of the last 15 years in many different areas including manufacturing floor processes, document control, device software development and validation and system development and validation, which included the implementation and adherence to FDA and international regulations. As the QA Manager for the I.S. department, Ms. Norton is presently responsible for assuring that all systems developed and maintained by I.S. in support of all R&D, clinical trial and manufacturing activities worldwide are properly validated prior to production release, and remain in a validated state through regular system maintenance and upgrade cycles. She was instrumental in the implementation and validation of electronic approval systems, using both biometric and non-biometric processes. Her expertise includes the practical and impractical techniques of the technical implementation, the regulatory requirements and the Information Services-related processes surrounding the implementation of 21 CFR Part 11. Ms. Norton has a BS in Electrical Engineering, with a minor in Computer Science.
Marcia Page specializes in medical device quality systems and design control systems that are compliant with the Quality System Regulation (QSR) of FDA and International organizations. Her expertise allows her to assist companies with the implementation of compliant quality systems including design control subsystems, perform thorough mock FDA audits, and identify problem areas that create roadblocks to the production of medical devices. She has a vast amount of experience helping a wide variety of medical device manufacturers get their products to the market in a compliant, yet profitable manner. Having over 20 years experience in the quality and regulatory field with a major medical device contract manufacturer and now as Director of Quality for Calypso Medical, Marcia has been intimately involved in the development of Quality Systems which comply with FDA QSR and ISO 9001/9002/13485, EN 46001/46002 including maquiladora operations in Mexico. She has worked with numerous manufacturers in achieving compliance during the manufacture of their products. Marcia has worked closely with FDA, various notified bodies, and has been an invited speaker by the FDA. She has been responsible for Quality Systems that have undergone seven (7) FDA QSR inspections, which have included inspections to the complete FDA QSR design control requirements and the QSIT approach with zero FDA-483 findings or observations. Marcia has been past President and Co-chair of the Organization of Regulatory & Clinical Associates (ORCA), FDA Grass Roots Partnering Committee member, RA/QA committee member for MDMA, and a charter member of the ASQC Quality Audit Division. Marcia attended Washington State University is also a member of RAPS and ASQ professional associations.
Rebecca Pine has over 16 years experience in the medical device industry assisting both industry-leading corporations as well as small business start-ups. She has helped facilitate her clients’ successes by directing and implementing regulatory strategies and executing aggressive project plans. She specializes in gaining U.S. and international regulatory approvals and implementing Quality Systems to assure both domestic and international regulatory compliance. She has significant experience in all aspects of domestic and international Medical Device Regulatory management, including Quality Assurance and Quality Systems. Ms. Pine is an expert in submission compilation and management including 510(k)’s, PMA’s, and CE Mark Technical Files & Design Dossiers. Her background includes Class I, II and III devices in the areas of IVD’s, hemostasis management, cold therapy systems, electro-medical devices (EMS/TENS), infusion pumps, and orthopedics devices including bracing (OTC and Rx), surgical instruments, as well as implantables, brachytherapy and mammography systems.
Christine Posin is a consultant, specializing in regulatory and quality assurance compliance issues in the medical device industry. Chris has over 33 years experience in the medical device industry assisting both large and small device manufacturers. In addition, Chris has also served as a Quality Education Instructor while with Johnson & Johnson. Prior to her career in the medical device industry, she was a health care professional in the respiratory and cardiopulmonary field which gave her valuable hands-on field experience. Chris is active in the Orange County Regulatory Affairs Discussion Group (OCRA). OCRA is a volunteer organization, located in southern California. Their purpose is to provide continuing education to regulatory professionals in the medical products fields. In May 1996 Chris organized a professional network group that focused on medical device reporting (MDR) and international reporting & vigilance, and facilitated this group for over 12 years. The MDR Network Group received the National Performance Review Hammer Award from Al Gore in 1999 as part of his program for innovations in government. Chris has a Bachelor of Science degree from Bowling Green University.
Raymond M. Pizinger has over 20 years experience in the medical device industry and is currently CEO of a medical device manufacturer. He specializes in international and US regulations which define design controls, CE Mark, software quality assurance, medical device reporting, and vigilance to mention a few. Mr. Pizinger worked with the FDA to implement the first electronic MDR reporting system and assisted the first medical device manufacturer to report MDRs electronically. Per the FDA's request and together with the FDA, he lectured at FDA's conference introducing the MedWatch process and new MDR regulations. He has also lectured on numerous occasions on subjects such as implementing a Quality System, design controls, software quality assurance, medical device reporting, vigilance, and the CE Mark certification process. Mr. Pizinger has implemented multiple Quality Systems that meet the requirements of ISO 9001, EN46001 and FDA's Quality System Regulation. He has also prepared numerous technical files and worked with multiple Notified Bodies to allow products to carry the CE Mark on products intended for the European Marketplace. He has also submitted and gained clearance on numerous 510(k)s, IDEs and has developed and implemented a regulatory review process for determining "510(k) vs no 510(k) required" decisions. Mr. Pizinger is a member of several professional organizations, including the American Society of Quality (ASQ) and Orange County Regulatory Affairs (OCRA). Mr. Pizinger's regulatory and quality experience includes executive management positions for companies producing both electronic and disposable devices including dialysis systems, ultrasonic imaging systems, blood analyzers and RIA devices, invasive blood sensors and catheters, critical care and home care ventilators, new generation sterilizers, cardiac arrhythmia monitors, centralized patient monitoring devices with networks both inside hospitals (LAN) and between hospitals (WAN) systems, interface software and medical telemetry. His academic training includes a B.S. in Biology from the University of California, Irvine, coupled with a minor in Bio-Engineering and graduate work in both electrical and mechanical engineering. His technical training is complimented with an M.B.A. in Management earned from the University of Redlands.
Dennis L. Rubenacker is co-founder and Senior Partner of the consulting firm of Noblitt & Rueland specializing in FDA electronic recordkeeping, design control, risk assessment, software development and software quality management for the medical device industry. He has extensive experience dealing with product development, software development and software quality assurance for medical device instrumentation. Mr. Rubenacker has held software engineering, software quality assurance, electronics engineering, project management, and management consulting positions in the research and development of medical devices, aerospace systems, and consumer electronics. His medical product line experience includes monitoring, diagnostic, and therapeutic critical-care devices. His experience includes clinical chemistry analyzers, immunoassay analyzers, microbiology analyzers, implantable & external defibrillators, glucose monitors, pacemakers, cardiac output computers, ejection fraction computers, oxygen saturation computers, retroperfusion pumps, cardiac imagers, EKG monitors, infusion pumps, catheter-sensor interfaces, home healthcare monitoring devices, as well as, manufacturing process instrumentation. He has been involved with the FDA, Los Angeles district, grass roots partnering subcommittee on electronic recordkeeping and has lectured on FDA electronic recordkeeping with several organizations including the Food and Drug Law Institute (FDLI). Mr. Rubenacker has assisted both domestic and international companies including companies ranging in size from less than $1,000,000 in sales to Fortune 100 companies. Mr. Rubenacker received his B.S. in Electrical Engineering with highest honors from the University of Illinois and is a member of the Institute for Electrical and Electronic Engineers (IEEE), RAPS, OCRA and ASQ.
Christine Ruther has extensive experience assisting the medical device industry with safety critical areas of compliance and regulatory engineering, including the requirements of electronic devices and wireless devices. During her career, Christine was the technical manager for the Medical Device Testing Group while at TUV Product Service, and directly managed the Medical testing and ISO/CE auditing activities for the southwestern region. Her responsibilities included conducting compliance testing for medical devices and performing audits of medical device manufacturers. After four years at TUV, Christine became the Compliance Manager for Cardiac Science in
Mike Schmidt has been actively involved in medical device regulatory and standards compliance for over twenty years. During that time he has acted as Secretary of Subcommittee 62D in the IEC (1996—Present), and is the convener of IEC SC62A/ WG18 (3rd edition of IEC 60601-1), he has also served as a technical expert working with the group that developed the IEC Collateral Standard 60601-1-4 (Programmable electrical medical systems), and in the joint ISO/IEC working group that developed and is currently amending ISO 14971 (Risk Management). He participates in the development and use of standards within the