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Pharmaceutical Science; Preformulating, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation
As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…
General Industrial Hygiene; Toxicology; Laboratory Safety; Hazard Communication; Chemical Hygiene
Expert has worked as a consulting industrial hygienist for 24 years. He is both a Certified Industrial Hygienist (CIH) and a Certified Safety Professional (CSP). He has conducted many detailed compliance evaluations/inspections and has developed helpful code interpretations for clients.…
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 Laboratory Science, Lab Directing, Lab Diagnostics, Medical Technology, Hospitals, Testing
Expert is a clinical laboratory scientist with 30 years of experience in the industry covering laboratories in the hospital, national reference, and large physician office settings. He is the founder of a consulting company which began in 2009. The company's…
Instrument Design and Development; Medical Devices, In-vitro Diagnostic Instruments; Clinical Laboratory Automation; Project Management; Planning, Scheduling, Budgeting. QSR and Design Control
Expert possesses a 30-plus-year track record managing medical device and in-vitro diagnostics development from concept to successful market introduction. A proven manager, he has accrued significant skills in leading diverse and multi-organizational teams in the successful development of leading edge,…
Medical Devices
Expert has about 10 publications on ablation. He published papers on this area and had grants to develop radio-frequency cardiac and liver ablation systems. He founded and directed a laboratory for medical device testing under IEC standards. Overview of Skills:…
Home Health Care, Home Infusion Therapy, Hospice, Molecular Diagnostics, Personal Assistance Service
Expert is a highly accomplished Healthcare Senior Sales Executive with thirty plus years of experience founding, funding, developing and helping others develop Emergent Health Care Companies, building territories and leading teams to achieve and surpass sales quotas. Successful background overseeing…
Injury Biomechanics, Biomaterials, Artificial Joint Implants, Tribology
Expert has applied her mechanical engineering background to biomaterials, biomechanics and nanotechnology for implantable devices in many industries. She has selected surface engineering process coatings, developed new operating procedures to mechanically test biomaterials used for orthopedic and injury biomechanics applications,…
wound healing, burns, clinical research, FDA regulations, drugs, devices, medical writing
Expert provides scientific knowledge and regulatory background to assist companies in the research and development of clinical, animal and laboratory studies designed to promote pharmaceutical drugs and medical device products specializing in wound healing and burn care. Additional Services: •Development…
Clinical Diagnostics, Immunoassay Product Development, Clinical Toxicology
Expert has two major areas of Expertise: 1) He has been involved in all aspects of In Vitro Diagnostic Immunoasasy and Clinical Chemistry Product Development Including Laboratory Research and Development, Transfer to Manufacturing, Documentation to meet QSR including Design History,…