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Retail Pharmacist & Expert Witness
Expert has been working full time as a Pharmacist in the retail sector for over 12 years. During this time, he's served as an expert witness in the pharmacy sector for over 10 years and has reviewed more than a…
Medical or Pharmaceutical R&D and Manufacturing – New Product Approval and Launch Including FDA, EMA, and Asia
40 years in design, manufacturing, R&D, and compliance. For the last twenty years have directed and led projects leading to over thirty 510(k), PMA, and NDA approvals in drug delivery, ophthomalogy, dental, cosmetics, emergency medicine, obstetrics, oncology, and diabetes. Clients…
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…
Sterility Assurance Expert in terminal sterilization (Ethylene Oxide, Moist Heat, Radiation, Dry Heat) and Aseptic Processing to Medical Device and Pharmaceutical companies.
. Expert is President and Principal Consultant for his consulting company - a consulting LLC. Prior to going into consulting, he was Director of Corporate Quality Technology/ Sterilization Science, for Alcon a Novartis company where he was responsible for sterilization…
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…
Pharmaceutical Manufacturing Processes, Quality Management, and FDA Interactions
Expert is a consultant to the US FDA for Quality issues associated with the manufacture of pharmaceuticals. Expert is a subject matter expert for the US FDA in Warning Latters and Consent Decree work and data Integrity issues. Expert provides…
Pharmaceutical Manufacturing, Combination Products, Medical Devices, and Good Clinical Practices
Expert is a retired Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals, Medical Devices, Biologics, and Bioresearch Monitoring. She has held the positions of Investigator, Pre-Approval Manager, Supervisory Investigator, and Foreign Inspection Cadre Member. She…
Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…
Human Response to Auditory Alarms and Visual Warnings, Auditory Alarm Design
Expert is an internationally-reknowned research professor with extensive expertise and experience in the area of human responses to alarms and warnings. This includes both speech and non-speech (buzzer-type) auditory warnings and written warnings labels. She has a 25-year research career,…
Allergy and Immunology, Asthma and Adverse Drug Reactions
Expert has co-edited a handbook on drug allergy and published sentinal papers on penicillin allergy, as well as management of bacterial endocarditis in the penicillin allergic patient. He is a practicing Allergist-Immunologist and has been a Clinical Professor of Medicine…