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Food & Drug Administration Rules, Policies, Procedures for Medical Devices and Pharmaceuticals
Expert is an FDA compliance expert with 28 years experience in the field. He served the U.S. Food and Drug Administration as an Investigator concentrating in compliance for pharmaceuticals and medical devices as well as pre-market development of drugs and…
Food Science and Technology with a Specialty in Food Safety
Expert J. Expert, Ph.D., F.A.A.M., F.I.F.T., is Distinguished Professor Emeritus of Food Science at Rutgers, the State University of New Jersey. Expert received his Ph.D. from M.I.T., his B.S. from Rutgers, and was a Senior Research Microbiologist at the United…
Food Safety and Integrity
Expert has over 30 years of experience helping the food industry and regulators protect food safety and integrity, respond to the evolution of the international food system, and prepare for rapid changes in technology. Expert spent over two decades developing…
Victim Advocacy; Training and Education
Promote healthy lives and relationships for the elderly, and disadvantage individuals of abuse, through education, safety planning and early intervention. Consulting and subject matter expert- victim advocacy, restorative justice and family reunification.
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…
Clinical Research, Clinical Trials, Drug Development, Drug Safety, Patient Consenting Process
Experienced clinical research professional with a demonstrated global leadership in the pharmaceutical and medical device industry. Global organization and oversight of clinical research, QA and regulatory strategies. Leadership in new business development (medical device and medical software development quality management,…
Pharmaceutical Development
Expert is a former FDA Review Chemist, with > 39 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 25+ years as a consultant in his own pharmaceutical development advisory firm, Expert has furnished clients with…
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,…
Food Safety and Quality
Expert is a professional food safety consultant and auditor who has been registered with SQF (the Safe Quality Food Institute) as such. He has accrued vast experience implementing food safety and quality assurance compliance systems for top-tier food manufacturing firms.…
Medical Devices, Pharmaceuticals, CMC, Regulatory Affairs, R&D, Design Controls, Autoinjectors, Syringes, and Manufacturing
Expert has extensive experience in Pharmaceutical and Medical Device industry. He managed multiple departments and spearheaded combination product activities to launch products. This included FDA/EMA meetings, Human Factor activities, Device Design and Development, Regulatory submissions, and Manufacturing responsibilities. He has…