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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…
Coatings & Process Engineering, Full Product Development Cycle
Expert is a Coating Engineer and Consultant with a history of success overseeing process engineering initiatives for next-generation product lines. He is a respected and authoritative leader of world-class teams accountable for wide range of processes within fast-paced, multi-facility manufacturing…
Pharmaceutical Dosage Forms
Expert is the founder and the President and Founder of a pharmaceutical technology company since 1997, and Adjunct Professor of Pharmaceutical Sciences, Faculty of Pharmacy, since 2019. Prior to that he was as a faculty member at the Faculty of…
Green and Clean Energy: Petrochemical, Refining, and Downstream Chemical and Utilities Sectors: Pre-commissioning, Commissioning, and Plant Startup
Executive summary: Expert has 17 years' experience in the petrochemical, refining, and downstream chemical and utilities sector. His experience includes pre-commissioning, commissioning, plant routine startup, shutdown, and emergency operations. His management roles include service as process trainer and process commissioning…
Fire Origin and Cause, Products Liability, Equipment Failure, Management, O&M Evaluation
Expert has performed accident investigation activities and assisted legal staff in preparing for court cases including providing sworn testimony regarding issues of fire and explosion origin and cause, equipment performance, manufacturing processes, and management negligence in personal injury cases. He…
Ergonomics
Expert is a board-certified professional ergonomist with over 30 years of experience. He has been in private ergonomics consulting practice since 2014, has worked for very large and very small companies (industries include: semi-conductor, technology/software, automotive, assembly, pharmaceutical, oil &…
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…
Formulation Chemistry
Spray drying expertise in volatile solvents and end-user food powder products. A lead formulation chemist with over eight years of experience in the area of the formulation. A talented chemist that excels in a high-performing multidisciplinary research environment in the…
Pharmaceuticals
During Expert’s 30 years in Pharmaceutical Research and Development, he developed extensive expertise in novel drug delivery systems and assessing external drug delivery companies while at Parke-Davis/Warner-Lambert, Pfizer and SCD Pharma Consulting. He also managed a team of scientist developing…
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,…