Qualifications:Pam Buckman has been involved in both the delivery of health care and the health care products industry for the past 30 years.

Primary Expertise:Development of FDA regulatory strategy programs for medical device manufacturers. Administration and management of clinical research studies and clinical evaluation programs. Management of professional associations in allied health care fields. Preparation and submission of required FDA documentation for research and/or premarketing purposes. Product development projects requiring clinical viewpoint analysis. Market research, product promotions and field surveys development and review. Regulatory due-diligence of potential acquisition candidates.

Industries Served:Orthopedic Implants * Medical End Textiles * Surgical Laser Systems * Cardiovascular Implants * Home Health Care Aids * Rehabilitation Equipment * Urological Devices * Wound Management Systems * Trauma Products * Dental Indications

Educational Experience Includes:

• Continuing Education: Participation in multiple annual educational seminars, academic courses and professional meetings throughout the country.
• Teaching: Instructor, University of California Santa Cruz Extension, Clinical Trials Design and Management Program. Industry seminars and workshops with emphasis in regulatory compliance and Good Clinical Practices.
• Credentials: Registered Nurse, California; Credential, Community College System, California; Regulatory Affairs - Certified
• Member: National Nurses in Business Association
• MS: University of California, Los Angeles, Psychiatric Nursing, Nursing Education
• BS: Mount St. Mary's College, Nursing, Psychology

Qualifications: Kay Davis has been involved in the delivery of health care since the early 1970s. For the past 20 years she has focused on educational strategies for implementing new processes and products.

Primary Expertise: Educational program development. Quality management systems. Regulatory compliance strategies. Program/product evaluation studies. Statistical analysis.

Industries Served: Emergency and critical care services - cardiovascular, pulmonary, trauma * Long-term care - rehabilitation, convalescent * Home-health care - mobility equipment, intravenous * Higher education institutions

Educational Experience Includes:

• Current Teaching Experience: Research Methods · Database Creation and Manipulation · Data Analysis and Interpretation · Technical Communication written, electronic and Internet based.
• Continuing Education: Participation in numerous national conferences and professional meetings. Course instructor and/or attendee regarding statistical analysis and technology strategies.
• Credentials: Registered Nurse, California; PHN; CCRN & MICN (inactive); Approved Continuing Education Provider
• Ed.D: Pepperdine University, Institutional Management
• MN: UCLA, Gerontology Clinical Specialist
• BSN: CSULB, Nursing

Qualifications: David Harris has over twenty years experience as Director of Research and Professor at medical schools. He has assisted numerous medical device companies to bring their products to market. He has over 100 publications in 12 medical specialties.

Primary Expertise: Basic science, preclinical animal studies, and design of clinical trials. Scientist, surgeon, educator and director of a research consulting firm, he is equally at home in the research lab, the OR and clinic, behind the podium, or in industry. Well experienced with the FDA process. Specializes in medical lasers and neurological devices.

Educational Experience Includes:

• MS in psychology, Ph.D. in neurophysiology.
• Professor of Psychology, Communicative Disorders, Otolaryngology, Anatomy, Surgery, Histology (current) and Dentistry (current).
• He has chaired 28 Medical/Scientific Conferences and Sessions, and organized over 80 CME training courses for physicians.

Qualifications: David Schlerf has specialized in several areas of the health care field such as trauma, orthopedics, epidemiology and health services management during the past 20 years.

Primary Expertise: 510(k), IDE, PMAA development-strategies and submissions. Evaluation of medical products for clinical readiness, regulatory status, and acceptability by the medical community. Regulatory audit management for CGP compliance. Presentation of health programs for public and professional education in areas of epidemiology, laboratory diagnosis of specific disease entities and public health obligations. Regulatory due diligence of potential acquisition candidates.

Industries Served:Regulatory Consulting Groups. Market Research Firms. Trauma Product Manufacturers. Public Health Departments. Medical Product Distributors. Home Health Care Agencies. Pharmaceutical Manufacturers. Dental Device Manufacturers.

Educational Experience Includes:

• Continuing Education: Attendance at multiple conferences and seminars pertinent to small business interests and specific areas of health care industry and delivery.
• Teaching: Conference and convention speaker for city school and community college systems Lecturer in Epidemiology. Small Group presentations in high technology medical product applications.
• Credentials: Hospital Corpsman, USN, Field Medicine Specialist, 1966. Licensed Vocational Nurse - California, 1969. Physician Assistant - Certified, 1974. Member of Regulatory Affairs Professionals Society.
• BBA: Health Services Management, National University, San Diego, CA 1978.

Qualifications: Karen Spritzer has over 16 years experience with the management, analysis and interpretation of data in research, education and corporate environments.

Primary Expertise: Design and creation of data base structures for analysis and interpretation using various statistical programs including STATA, SAS, and SPSS. Management of large data sets with extensive experience in the transfer and merging of data files.

Outcomes-Based Research Areas: Renal Transplants * Ophthalmology * Quality of Life Surveys * Exercise and Smoking * Orthopaedic Implants * Capitation in Healthcare Psychiatric Disorders * Patient Satisfaction Surveys.

Educational Experience Includes: BA degree in Psychology and Mathematics with a concentration in Statistics from Boston University. In addition, 2-3 years of graduate level coursework in nonparametric statistics, multivariate statistical analysis, regression analysis, probability theory and epidemiology at Boston University and the Harvard School of Public Health.

Instruction: Over 10 years experience teaching statistical analysis content courses to colleagues and graduate students. Extensive experience with one-on-one tutoring in statistics and various computer applications.

Publications: Co-author of over 20 articles published in professional journals including: Archives of Internal Medicine, Quality of Life Research, Archives of General Psychiatry, Ophthalmology, Archives of Ophthalmology, Journal of Clinical Epidemiology, Annals of Neurology. Complete publication list available upon request. Industry seminars and workshops with emphasis in regulatory compliance and Good Clinical Practices.

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Qualifications: Jim Stout has been involved in the health care industry, in health care delivery, research, and medical devices, since 1966.

Primary Expertise: Development of quality systems for medical device manufacturers, including compliance with FDA's GMP regulation and ISO 9000 quality standards. Training in process mapping, quality systems, and internal and vendor auditing. Development of documentation for CE mark certification. Internal and vendor audit development, training and conduct. Product development projects requiring clinical viewpoint analysis. Preparation and submission of required FDA documentation for premarketing purposes. Regulatory and quality due diligence.

Industries Served: Cardiovascular * Capital Equipment * Ultrasound * Orthopedic * Dental Implants * Surgical Sutures * Urological Laser * Ob/Gyn Surgical Instruments

Educational Experience Includes:

• JD: Suffolk University
• MQM: Loyola University, Masters in Quality Management
• Graduate Work: Nutritional Biochemistry, MIT
• BS: Biological Sciences (with honors), Lowell Technological Institute
• Continuing Education: ISO 9000 Lead Auditor, Perry-Johnson, Inc.