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Physical Therapy
1969 B.S. SUNY Downstate College of Health Related Professions, 1971 M.S. Exercise Physiology Long Island University, Masters Degree Thesis: A Comparison of the Effectiveness of Eccentric Vs. Concentric Strength Training Programs on the Contractile Strength of the Elbow Flexors. 1995…
Clinical Nursing, Critical Care and Ambulatory Services
Expert has 38 years of nursing experience, is Master's prepared, and is Adult Critical Care Certified. She is a Certified Clinical Nurse Specialist with expertise on Ambulatory Care, Neuroscience, and Critical Care. Expert is also, Manager of a COVID-19 testing…
Mental Health: Trauma, Personality Disorders, and Psychopathy
Expert is a forensic psychologist specializing in familial dysfunction and traumatic experience and marriage. She is a family therapist. Mental Health Leader, Clinical Investigator, and Academic Subject Matter Expert with the ability to understand and influence basic and translational research…
Medical Device Quality Assurance and Regulatory Compliance
Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…
Pharmacovigilance
Pharmacovigilance professional with 18 years’ experience developing and reengineering PV departments in small to medium sized pharmaceutical/biotechnology companies. Operational expertise includes the evaluation, development and implementation of PV processes and infrastructure, vendor management, SOP development and revision, CAPA management, compliance…
Pharmacokinetics/Pharmacodynamics
Expert has over 37 years of experience in the pharmaceutical industry, including work as an independent consultant. As a consultant he offered preclinical and clinical pharmacokinetic, pharmacodynamic, and pharmacometric support services, with emphasis on providing strategic planning services throughout a…
Formulation
Pharmaceutical product development, scale-up, commercial manufacturing. Process design, improvements, economic changes. Complex product development, bioavailability, absorption enhancement. Intellectual property analysis and guidelines for alternative strategies. Sourcing, quality, regulatory CMC guidance. Proven track record of 30 years in effective product development…
Oncology, Hematology
ACADEMIC BIO SKETCH: Expert holds the rank of Professor of Hematology/Oncology, is a 33 year veteran of academic medicine, a key opinion leader and skilled principal investigator of over 200 clinical trials and has published over 100 peer-reviewed articles in…
Equipment Validation
Experienced pharmaceutical process engineer with demonstrated ability in managing, supporting, and formulating in a dynamic environment. EQUIPMENT EXPERIENCE Ackley Imprinter Glatt - GPCG-1, GPCG Pro-5, VG Pro 65, Midi Glatt, VG-25, Glatt SKS-100 valves. Korsch - XL400WIP,…
Medical Devices, Business Development, Regulatory Affairs, Project Management
Expert successfully launched over 25 new instrument and disposable medical devices. He developed and managed numerous cross-functional and cross-cultural new product and process teams. He has developed rich experience in team leadership and assembly, grounded in RA/QA fundamentals (RAC Certified).…