Strategic Committee
FDA/Xavier University Medical Device Conference, May 4-10, 2010
Francis Blacha, Global Quality Leader – Devices. Eli Lilly and Company. In his current role, Francis is responsible for quality oversight of delivery device research and development and device manufacturing with sites in US, France, Italy, Germany and Japan. Prior to joining Eli Lilly, Francis held various quality leadership roles in pharmaceuticals and devices with Pfizer and Glaxo. He has 20+ years of industry experience in guiding both pharmaceutical and medical device projects teams in all aspects of quality in support of product lifecycle management. He has extensive compliance and inspectional experience with various regulatory agencies and notified bodies. He holds a Bachelor of Arts degree in Chemistry from Catawba College and a Master of Science degree in Chemistry from North Carolina State University.
Paul Brooks, Vice President – Country Manager. BSI Product Services. Paul has worked with BSI since 1981, and is now responsible for leading BSI activities in the medical devices regulatory sector including EU Notified Body, EU/US Conformity Assessment Body, Health Canada / SCC CMDCAS accreditation and US FDA recognition. Paul was called upon to present and provide input on the FDA Modernization Act 1997, particularly regarding the use, role and acceptance of third party conformity assessment in regulatory requirements. Paul is a long standing member and Board Director of the Regulatory Affairs Professional Society (RAPS) and a member of American Society for Quality (ASQ) – Biomedical Division. He routinely presents and trains for RAPS, ASQ, AAMI, and AdvaMed. Paul was invited in Spring 2007 to join an International Accreditation Forum (IAF) Working Group to explore the wider acceptance of accredited ISO 13485 certification as a basis for helping to meet regulatory requirements for emerging regulations around the world.
Karen A. Coleman, Senior Compliance Expert, Medical Devices. IHL Consulting Group, Inc. Karen retired after 30 years with FDA, the last 15 of which she was a Medical Device National Expert. Karen served as FDA Certified Device Investigator and a Medical Device Performance Auditor. She conducted cGMP and Pre-Market inspections both domestically and internationally involving complex devices, sterile devices, tissue devices, diagnostics, and radiological equipment. She served as a principal FDA instructor in the agency for FDA Quality Systems training courses and Industrial Sterilization. She was an instrumental FDA representative on the Global Harmonization Task Force (GHTF), Study Group 4 on Auditing. She received special agency recognition at the highest levels including the Commissioner’s Special Citations, Commendable Service Awards, and Outstanding Service Awards. Karen holds a Bachelor of Science degree from the University of Montevallo and a Master of Science degree from Auburn University.
Barbara Fant, Pharm.D, Principal Regulatory Consultant and President. Clinical Research Consultants, Inc. Barbara has 25 years of experience in pharmaceutical and medical device research and development. CRC has successfully filed over one hundred IDE’s, pre-IDE’s, 510(k)’s, and PMA’s with the FDA to bring investigational products to the marketplace. Dr. Fant served chair of the ANSI Z80.11 committee for 3 years and chair of its clinical subcommittee for 5 years; recently co-chaired the Drug Information Association’s (DIA) Medical Device Symposium; is a past chairperson of the DIA’s Medical Device Special Interest Group Program Committee; coordinates the medical device lecture series for the University of Cincinnati’s Master’s Program; serves on the Board of Directors for Medennium, Inc; is the founder of the VEO Research Consortium; and is the founder of the Integrated Center for Device Development. She holds a B.S. in Pharmacy from Ohio Northern University and a Doctor of Pharmacy degree from the University of Cincinnati.
Barbara Immel, President. Immel Resources LLC. Barbara has worked with pharmaceutical, biotechnology, and medical device companies in more than 20 countries, and has been teaching compliance classes for more than 20 years. Before starting her company in 1996, Barbara gained more than 12 years of hands-on experience in quality assurance and regulatory compliance at Syva Company, Chiron Corporation, and Syntex Corporation. Barbara served as the regulatory compliance columnist for BioPharm magazine for more than 10 years. She is editor of the Immel Report™ newsletter, which provides advice and guidance for managers in FDA-regulated industry. She has published more than 50 articles in Medical Device & Diagnostic Industry, Pharmaceutical Technology, Pharmaceutical Technology Europe, BioProcess International, Nutraceutical Business and Technology, and BioPharm. Barbara serves as chairperson of the annual FDA Inspections Summit hosted by FDAnews, and is a graduate of the University of California, Santa Barbara.
Chris Nelson, Consultant. Marsh USA Inc. Chris provides consulting services and training on FDA’s quality system requirements for medical device manufacturers. Chris worked for FDA’s Center for Devices and Radiological Health (CDRH) for 15 years, first in the Office of Compliance and then in the Division of Small Manufacturers, International and Consumer Assistance. She evaluated medical device manufacturers for compliance to the GMP and Quality Systems Regulations to support legal actions. She provided advice, guidance and training on the Quality System regulation and other device regulations to FDA headquarters and field staff, the medical device industry and foreign government officials. From 1995 to 2005, Chris was FDA’s representative on the Global Harmonization Task Force’s Study Group working to achieve international harmonization of regulatory auditing of device manufacturers. From 2000 until 2006, Chris coordinated CDRH’s international activities. She received a BS degree from Northern Illinois University and a MS degree from the University of Illinois.
Marla A. Phillips, Ph.D., Director of Med-XU. Xavier University. Prior to Xavier, Marla was a Senior Compliance Consultant with 12 years of domestic and international experience in the Pharmaceutical Industry. Marla provided analytical, manufacturing, and packaging technical reviews; conducted compliance and technical training; performed mock-PAI and GMP inspections; and assisted companies in developing responses to FDA observations and Warning Letters. Prior to consulting, Marla was employed by Merck & Co. as a site Director of Quality Operations responsible for manufacturing, packaging, testing, joint venture relations, contract packaging operations, and management of the North American stability program. Marla holds a B.S. in Chemistry from Xavier University, and a Ph.D. in Organic Chemistry from the University of North Carolina.
Ken Sumner, Ph.D., Worldwide Vice President of Clinical & Regulatory Affairs. Ethicon Endo-Surgery, Inc., (A Johnson & Johnson Company). Ken has held this position since joining EES in October 2004, and is also a member of the U.S. Board of the Company. Prior to joining EES, Ken was Vice President, Regulatory Affairs and Quality Assurance for Eunoe, Inc., a medical device start-up company in California. He has led various regulatory and clinical organizations in the medical device industry including those at Zimmer, C.R. Bard, and Nellcor Puritan Bennett, as well as at several start-up companies including Cytyc, Inc. Early in his career he was an associate professor of chemistry at Bridgewater State College in Massachusetts. Ken holds a B.S. in Chemistry from Union College, Schenectady, NY and a Ph.D. in Biochemistry from the State University of New York, Upstate Medical Center in Syracuse. Ken also completed post-graduate work at the University of Chicago.
Monica Wilkins, Senior Director, Corporate Quality Assurance and Compliance. Abbott Laboratories. Prior to joining Abbott, Monica was employed by the Food and Drug Administration (FDA). Monica held the positions of a Medical Device National Expert, Compliance Officer, Medical Device Specialist, and Investigator. As a National Expert, her responsibilities included the conduct of domestic and international inspections; providing assistance to all Centers, Districts, Industry, Investigators and other government agencies; development of training curriculum; classroom instruction at the FDA national courses and industry seminars/workshops; on-the-job training for investigators; and assisting in the review and development of policies and guidance documents. She has twelve years of experience in performing medical device and pharmaceutical inspections for the FDA. She holds a Bachelors degree in Microbiology from the University of Texas at Austin.
Advisory Members to the Strategic Committee
Gina Brackett, Compliance Officer – Medical Device Specialist. FDA, Cincinnati District Office. Gina has been with the Food and Drug Administration since 1990. . Prior to taking the compliance officer position, she was the Medical Device Specialists in the Cincinnati District Office for 7 years. She is still a medical device performance auditor; and the majority of her case work involves medical device firms. She graduated from Thomas More College, Crestview Hills, KY with a bachelor’s degree in Biology and an associate’s degree in Chemistry.
Michael Marcarelli, PharmD, MS. Director, Division of Bioresearch Monitoring. Office of Compliance. FDA Center for Devices and Radiological Health. Michael holds a B.S. from Northeastern University, a PharmD from University of Arkansas, and M.S. from Johns Hopkins University.
